OBJECTIVES/GOALS: We aim to identify and characterize anti-Sox2-specific CD8+ T cell responses in stable MUGS patients expressing HLA class I alleles-A*02:01 and /or -B*07:02. METHODS/STUDY POPULATION: Cross sectional study of patients with stable MGUS defined as stable serum paraprotein for ≥ 12 months from the MM Research Clinic at the Abramson Cancer Institute. Sox2 T cell reactivity will be assessed by IFN-γ ELISPOT assays. Rested PBMC will be pulsed with candidate Sox2-derived peptides predicted to display high affinity to HLA class I alleles and known to be processed and presented as determined by “targeted MS/MS” (mass spectrometry). The presence of anti-Sox2-specific CD8+ T cells will be confirmed in peptide/HLA multimer assays using flow cytometry. Anti-Sox2-specific CD8+ T cells will be characterized for HLA restriction and TCR αβ composition. RESULTS/ANTICIPATED RESULTS: Our work is still in progress. From Aug to Dec 2019, 22 MGUS subjects have been analyzed, 11 of which were found to have the HLA of interest. Positive Sox-2 reactivity by ELISpot was found in 3 subjects. DISCUSSION/SIGNIFICANCE OF IMPACT: Anti-Sox2 immune responses may maintain MGUS in a clinical indolent state by eliminating Sox2-expressing clonogenic MM cells. A detailed characterization of anti-Sox2 T cells followed by in-vivo assessment of their anti-myeloma activity could provide the foundation for a Sox2 based immunotherapy approach in MM.

OBJECTIVES/SPECIFIC AIMS: Our objective was to assess and compare the attitudes of patients with head and neck cancer and their clinicians regarding the commercialization of genetic research data. We explored whether such opinions changed when profits from such transactions were used to fund 1) cancer research, 2) academic research generally, or 3) if patients were given personalized genetic information in return. METHODS/STUDY POPULATION: This qualitative analysis was nested within a prospective precision oncology genomic sequencing study in an NCI-designated cancer center. We conducted paired, semi-structured interviews with enrolled participants with head & neck cancer and with their doctors (medical oncologists, surgical oncologists, and radiation oncologists). Interviews were recorded, transcribed, and coded for analysis. Codes were developed through an iterative process until saturation was reached, and all transcripts were double-coded (and discrepancies reconciled) to ensure reliability. RESULTS/ANTICIPATED RESULTS: We identified three main themes from the patients and clinicians: (1) Both clinicians and their patients were unclear about how the study protocol and informed consent form authorized patients’ genetic data to be used and commercialized in the future. (2) Patients with cancer were generally more comfortable than their clinician thought they were regarding the ongoing research use of their genetic data and commercialization thereof. (3) There is a strong interest among patients and clinicians in focusing academic medical center profits from commercialization back into the research program from which the data was acquired, rather than being invested into academic research more broadly. DISCUSSION/SIGNIFICANCE OF IMPACT: Given patients’ strong feelings about the commercialization of their data, our results highlight the need for greater transparency—both with patients and with their clinicians—about potential future use of research data. Clinicians appear inclined to be particularly cautious regarding access to and commercialization of patients’ data, however patients generally hope that their data may be used to help future cancer patients. Explicit discussions with patients about specific future uses of profits derived from commercialization of research data can ensure both transparency and participation in future primary and secondary precision health research programs.

OBJECTIVES/GOALS: Estimating kidney function for drug dosing poses safety and efficacy concerns with critical medications. This study aims to develop a pragmatic method for measuring kidney function, ensuring that critical clinical decision points based on kidney function are universally applicable to all patients, leading to improved health outcomes. METHODS/STUDY POPULATION: This is a single-dose pharmacokinetic (PK) study to evaluate the concordance between iopamidol- and iohexol-measured glomerular filtration rate (mGFR), as determined by their respective serum clearances, in a cohort of 24 adults with varying kidney function. Participants with estimated glomerular filtration rates (CKD-EPI eGFRcr) ranging from >30 to 120 mL/min will be recruited from the Michigan Medicine health system. Enrolled participants will be stratified into 3 kidney function groups based on conventual kidney dosing considerations. IV micro doses of iohexol and iopamidol will be administered, followed by blood sampling. PK analysis will be used to compare the clearance of these substances. The agreement between iohexol and iopamidol in measuring GFR will be assessed via bioequivalence analysis. RESULTS/ANTICIPATED RESULTS: We expect no statistically significant difference between iopamidol and iohexol CL due to the high similarity of iopamidol and iohexol molecular and PK properties. We also expect that the ordinary least square regression analysis of iopamidol mGFRand iohexol mGFR will show limited variability across GFR measurements. These expected results will support the use of iopamidol as a marker of mGFR and its interchangeability with the gold standard iohexol. DISCUSSION/SIGNIFICANCE: Addressing eGFR errors is crucial for accurately dosing critical medications. This study aims to develop a novel mGFR methodology that accommodates various kidney function levels. This will enable precision dosing and streamline clinical trials. It also eliminates biological variability, enhancing generalizability and health outcomes.

OBJECTIVES/GOALS: Neuroblastoma (NB) is the most common extra-cranial solid tumor with outcomes varying from spontaneous regression to metastatic with high mortality rates. The tumor immune microenvironment (TIME) may play a significant role in this disease. In this study we analyze the TIME comparing high-risk (HR) and low-risk (LR) NBs using multiplex platforms. METHODS/STUDY POPULATION: Two tissue microarrays (TMAs) with 2mm cores were created from 41 patients treated at Columbia University Irving Medical Center. Five micron TMA slides were stained for Digital Spatial Profiling (DSP, nanoString) and multiplex immunofluorescence (mIF). For DSP, a 24-patient subset including 11 HR, 8 LR and 4 intermediate risk patients was analyzed for 34 proteins. Protein expression among risk groups was compared using Mann-Whitney t-test. For mIF, TMA FFPE slides were stained for DAPI, CD3, CD8, CD68, HLA-DR, PDL1 and Chromogranin A. Whole TMA cores were captured as 9 -20X multispectral images (MSIs) stitched into a 3x3 MSI using Vectra (Akoya). MSIs were processed with inForm and qualitative analysis performed comparing HR and LR tumors. RESULTS/ANTICIPATED RESULTS: With DSP, we find significantly more HLA-DR in HR compared to LR tumors (p = 0.016). When controlling for immune cells with CD45 we find HLA-DR/CD45 to be higher in HR than LR tumors (p = 0.026). We found increased PD1 and PDL1 expression in all groups without significant difference between LR and HR (p = 0.778 and p = 0.310, respectively). Preliminary analysis of mIF on 9 patients (4 HR and 5 LR) finds HR tumors appear to have more immune cells than LR tumors, specifically more CD3+CD8- T cells while total CD8+ cells may be similar. There may be less macrophages in the HR compared to LR tumors. Completion of image processing and quantitative analysis of mIF data is underway. DISCUSSION/SIGNIFICANCE OF IMPACT: Increased expression of immune markers in NB TIME correlates with higher risk, which is unlike many other tumors. We compared TIME in HR and LR NB using multiplex platforms, DSP and mIF. We find that HLA-DR is more expressed in HR NB while PD1 and PDL1 expression is consistently high and not different between risk groups. Further analysis is underway. CONFLICT OF INTEREST DESCRIPTION: Robyn D. Gartrell-Corrado received grant support from nanoString for Digital Spatial Profiling and received honoraria and travel support from Northwest Biotherapeutics and PerkinElmer, respectively.

OBJECTIVES/GOALS: Clinical indicators predictive of venous thromboembolism (VTE) in trauma patients at multiple time points are not well outlined, particularly at time of discharge. We aimed to describe and predict inpatient and post-discharge risk factors of VTE after trauma using a multi-variate regression model and best of class machine learning (ML) models. METHODS/STUDY POPULATION: In a prospective, case-cohort study, all trauma patients (pts) who arrived as level 1 or 2 trauma activations, from June 2018 to February 2020 were considered for study inclusion. A subset of pts who developed incident, first time, VTE and those who did not develop VTE within 90 days of discharge were identified. VTE were confirmed either by imaging or at autopsy during inpatient stay or post-discharge. Outcomes were defined as the development of symptomatic VTE (DVT and/or PE) within 90 days of discharge.A multi-variate Cox regression model and a best in class of a set of 5 different ML models (support-vector machine, random-forest, naives Bayes, logistic regression, neural network]) were used to predict VTE using models applied a) at 24 hours of injury date or b) on day of patient discharge. RESULTS/ANTICIPATED RESULTS: Among 393 trauma pts (ISS=12.0, hospital LOS=4.0 days, age=48 years, 71% male, 96% with blunt mechanism, mortality 2.8%), 36 developed inpatient VTE and 36 developed VTE after discharge. In a weighted, multivariate Cox model, any type of surgery by day 1, increased age per 10 years, and BMI per 5 points were predictors of overall symptomatic VTE (C-stat 0.738). Prophylactic IVC filter placement (4.40), increased patient age per 10 years, and BMI per 5 points were predictors of post-discharge symptomatic VTE (C-stat= 0.698). A neural network ML model predicted VTE by day 1 with accuracy and AUC of 0.82 and 0.76, with performance exceeding those of a Cox model. A naīve Bayesian ML model predicted VTE at discharge, with accuracy and AUC of 0.81 and 0.77 at time of discharge, with performance exceeding those of a Cox model. DISCUSSION/SIGNIFICANCE: The rate of inpatient and post-discharge VTEs remain high. Limitations: single institution study, limited number of patients, internal validation only, with the use of limited number of ML models. We developed and internally validated a ML based tool.Future work will focus on external validation and expansion of ML techniques.

ABSTRACT IMPACT: Regional health issues can be best addressed at the population-level and input from the communities is vital for prioritization of health issues. OBJECTIVES/GOALS: The Great Plains IDeA-CTR (GP IDeA-CTR) was developed to increase clinical and translational research (CTR) that can address regional health priorities. Here we describe a collaborative process used to identify regional health priorities using existing surveillance data and community input. METHODS/STUDY POPULATION: We used a participatory approach that included a partnership between the GP IDeA CTR Community-Engagement and Biostatistics, Epidemiology, and Research Design Cores to ensure priorities were data driven and also aligned with community-based perceptions of need. First, aggregated surveillance data across Nebraska, North Dakota, and South Dakota was presented to the GP IDeA CTR Community Advisory Board (CAB). Second, CAB members formed small groups and considered the information and generated priority health area lists. Third, small group lists were considered and discussed by the full CAB to finalize priority areas. Finally, the CAB reviewed the priorities annually thereafter. RESULTS/ANTICIPATED RESULTS: We identified priority areas for CTR that included (1) behavioral health, (2) injury prevention, (3) obesity, (4) technology to improve health care access, (5) connecting clinical/community services, and (5) addressing health disparities. These priorities align with population-based surveillance data that show lack of mental health care access, high prevalence of obesity, higher incidence of accidents, and existing racial, ethnic, and geographic health disparities. The CAB highlighted that research was also needed to improve how people can access the health innovations developed through CTR to address the other priority health issues with a goal to have an impact on population health. DISCUSSION/SIGNIFICANCE OF FINDINGS: By integrating data- and community-driven approaches we identified regional health priority areas that if addressed, can have significant impact in the GP IDeA CTR region. The priorities are listed on all GP IDeA-CTR funding announcements to encourage CTR in these areas.

OBJECTIVES/GOALS: Intravenous immunoglobulin (IVIG) is used for infection prevention in pediatric B-cell acute lymphoblastic leukemia (B-ALL), but evidence for this is lacking. We describe the prevalence of hypogammaglobulinemia in pediatric B-ALL, predictors of IVIG use and its efficacy for infection prevention. METHODS/STUDY POPULATION: We will conduct a retrospective review of children age 1-21 years with B-ALL treated at Aflac Cancer and Blood Disorders Center from 2010 to 2017. The cohort was identified through the cancer registry. Demographics, disease factors, laboratory values, medications and infection outcomes were linked between the electronic medical record and an institutional database. Outcomes of interest include emergency department (ED) visits, hospitalization days, and episodes of infection. Descriptive statistics will be performed. Outcomes will be compared between IVIG recipients and non-recipients. Univariate and multivariate logistic regression models will assess predictors of IVIG administration. RESULTS/ANTICIPATED RESULTS: We identified 443 patients with B-ALL during the study period who met inclusion criteria. Exclusion criteria included receipt of IVIG or hematopoietic stem cell transplant prior to diagnosis. The average age at diagnosis is 6.5 years (standard deviation 4.8 years); 52.6% are male; 61.6% are white; 61.0% are standard risk per National Cancer Institute criteria. Among eligible patients, 137 (31.1%) received IVIG. We hypothesize that IVIG initiation is associated with hypogammaglobulinemia and history of severe infection. We also anticipate that frequency of emergency department visits, hospitalization days, and episodes of infection will decrease after IVIG initiation. DISCUSSION/SIGNIFICANCE OF IMPACT: The immunological profile of children with B-ALL and factors influencing their susceptibility to infection are still incompletely understood. The benefits of IVIG are unknown. This study will provide evidence for IVIG prophylaxis recommendations in pediatric leukemia patients.

OBJECTIVES/SPECIFIC AIMS: Immigrants to North America receive more interventions at end of life.The reasons for this are not entirely clear but may potentially be due to knowledge gaps. The primary objective of this study was to measure and describe levels of perceived knowledge about palliative care among immigrants to the US compared to those born in the US. Our secondary objective was to identify trusted sources for seeking information about palliative care among immigrants and compare these trusted sources with those born in the US. We hypothesized that immigrants would have less knowledge of palliative care than those born in US and would trust different sources for information about palliative care. METHODS/STUDY POPULATION: We analyzed data from the nationally representative 2018 Health Information National Trends Survey (HINTS 5, cycle 2). Questionnaires were administered via mail between January and May 2018 to a population-based sample of adults. The primary outcome of interest was assessed using the item “How would you describe your level of knowledge about palliative care?” The secondary outcome of interest was determined using the item “Imagine you had a strong need to get information about palliative care, which of the following would you most trust as a source of information about palliative care?” All analyses were complete case analyses and conducted with survey commands using SAS 9.3 (SAS Institute Inc, Cary, NC, USA). Descriptive statistics were calculated, and bivariate analyses run between the outcomes of interest and sociodemographic characteristics (age, sex, education, race/ethnicity, nativity, English language proficiency). Multivariable logistic regressions were conducted to assess the role of nativity, controlling for statistically significant and relevant sociodemographic variables. Jackknife weighting was used to generate population-level estimates. RESULTS/ANTICIPATED RESULTS: The response rate was 33% (n=3384) and included 2846 (85.3% weighted) born in the US and 492 (14.7% weighted) not born in the USA. About 70% of those born in the US and 77% of immigrants (weighted) responded that they had “never heard of palliative care.” Trusted sources of palliative care were very similar between the groups (all p > 0.05). Both groups’ preferred trusted source of palliative care knowledge was “health care provider,” with over 80% of respondents in each group selecting this option. Printed materials and social media were the least popular trusted sources among both groups. After adjusting for relevant sociodemographic characteristics, we found no association between poor knowledge of palliative care and nativity (p=0.22). Female respondents had 2.5-fold increased odds of reporting low levels of perceived knowledge of palliative care (OR = 2.58, 95% CI = 1.76-3.78; p<0.001). Education was an important predictor of perceived knowledge of palliative care; as education level increased, so did perceived knowledge of palliative care (p < 0.001). DISCUSSION/SIGNIFICANCE OF IMPACT: Perceived knowledge of palliative care is poor generally, regardless of birthplace. Trusted sources for palliative care are similar between immigrants and those born in the US. Education is important and is a strong predictor of perceived knowledge of palliative care. Women perceive they have lower levels of knowledge of PC than men. Differences in end of life care between immigrants and non-immigrants cannot be explained by knowledge differences. Further research is needed to examine the potential factors including suboptimal communication between providers and immigrant patients to understand why these differences are noted. Future strategies for improving knowledge of palliative care should target health care providers as the key trusted source of information to help address deficits noted in this study.

OBJECTIVES/GOALS: We have designed an analogue of the Vitamin E tocotrienols called tocoflexol, which improves their pharmacokinetic limitations to make it an effective radiation medical countermeasure. Our goal is to demonstrate that tocoflexol is an effective radiomitigator in vivo when administered after exposure to lethal doses of total body irradiation. METHODS/STUDY POPULATION: Tocoflexol was designed using computational techniques to improve binding to ATTP, the key transporter that reduces the rate of elimination of tocols. In vitro studies compared the antioxidant and cell uptake properties to conventional tocotrienols. Next, we used a mouse model of lethal total body irradiation to evaluate its radioprotection efficacy (treating before radiation). To determine the optimal administration route for radiomitigation (treating after radiation), we will test oral and subcutaneous dosing. Mouse survival will be monitored for 30 days after irradiation. Sample tissues will be taken to evaluate the ability of tocoflexol to protect key organs from acute radiation syndrome. The bioavailability of tocoflexol will be evaluated in a rodent model. RESULTS/ANTICIPATED RESULTS: Known Results: Results show that tocoflexol has potent antioxidant properties and high cell uptake. When tocoflexol was administered 24 hours before exposure to lethal doses of radiation, tocoflexol-treated mice showed 100% survival. Anticipated Results: Because of its improved bioavailability and pharmacokinetic properties, we expect that tocoflexol will show radiomitigation efficacy when administered 24 hours after radiation, improving survival and protecting key organ systems from acute radiation syndrome. DISCUSSION/SIGNIFICANCE: There is an unmet need for safe and effective radiomitigators that can offer multi-organ protection and be rapidly administered in the event of nuclear emergencies. Demonstration of radiomitigation efficacy will position tocoflexol as a prime candidate to be developed into a nuclear medical countermeasure and stockpiled for emergencies.

OBJECTIVES/GOALS: The objective of this study is to examine the relationship between gastro-intestinal (GI) patients’ health literacy levels and patients’ health outcomes (length of stay, readmission, complication). METHODS/STUDY POPULATION: A research team at the University of Alabama at Birmingham (UAB) ‘s Gastro-Intestinal (GI) surgical department collected inpatient GI patients’ health literacy data by distributing the Brief Health Literacy Screen (BRIEF) survey to patients are about to be discharged. Patients’ health outcomes data were gathered through Business Objects, an online platform that allows physicians and researchers to access and gather patients’ medical information with an IRB approval. After accounting for necessary control variables, logistic regression and multiple linear regression models will be run to assess whether there is a significant relationship between patients’ health literacy levels and patients’ health outcomes. RESULTS/ANTICIPATED RESULTS: Three specific hypotheses are proposed in this study. H1: GI patients’ health literacy levels will be negatively associated with their lengths of stay H2: GI patients’ health literacy levels will be negatively associated with their readmission status to the hospital H3: GI patients’ health literacy levels will be negatively associated with their complication status to the hospital DISCUSSION/SIGNIFICANCE OF IMPACT: This study allows us to further our understanding of patients’ health literacy level and its’ relationship with important health outcomes. By looking at a variety of diverse health outcomes, the impact of a patients’ health literacy level on that patients’ health outcomes will be observed more clearly.

ABSTRACT IMPACT: Improved understanding of the relationship between level of response to alcohol and body weight in the context of other contributing factors will help inform prevention and intervention efforts regarding obesity. OBJECTIVES/GOALS: We evaluated the association between level of response to alcohol and weight status across the spectrum of alcohol misuse. We hypothesized that lower level of response to alcohol would be associated with heavier weight, after controlling for obesity risk factors like food addiction, impulsivity, and low socioeconomic status. METHODS/STUDY POPULATION: Adult participants (N=587) enrolled in NIAAA’s natural history study completed Self-Rating of the Effects of Alcohol (SRE), a retrospective measure of level of response to alcohol, along with Lifetime Drinking History (LDH); Yale Food Addiction (FA) Scale; Barratt Impulsiveness Scale (BIS); Delayed Discounting Task (DDT). Structured Clinical Interviews for DSM disorders were conducted to identify individuals with current alcohol use disorder (AUD). Body mass index (BMI), computed from height and weight measured during the study, and used to stratify participants into 3 groups: normal weight (N=222), overweight (N=219), or obese (N=146). RESULTS/ANTICIPATED RESULTS: SRE scores during heaviest drinking period were lowest in the heavier weight group, after accounting for FA, impulsivity, alcohol-related, and demographic variables (ê•2=238.5, p=0.002, Cox and Snell Pseudo R2=0.43). Compared to the obese group, normal weight and overweight groups had fewer FA symptoms and higher BIS cognitive complexity (p values<0.01) but similar rates of current AUD. Relative to the obese group, the normal weight group was more likely to be White, and to have lower household incomes but more education, more years of heavy drinking (LDH), and steeper delayed discounting, p values ≤0.03. The overweight group had a higher proportion of males than did the obese group, p<0.001. DISCUSSION/SIGNIFICANCE OF FINDINGS: Lower level of response during heaviest drinking period was significantly associated with current weight status, suggesting a relationship between alcohol sensitivity and BMI. Future work will explore pharmacokinetic-pharmacodynamic and additional risk factors underlying this relationship.

OBJECTIVES/GOALS: Annually, 1.5 million global patients receive maxillofacial reconstruction. The gold standard, involving bone particulate, lacks reproducibility. To improve this, we have developed a custom 3D-printable, porous cover-core design. This study optimizes the hydrogel core properties and growth factor (GF) release for enhanced bone regeneration. METHODS/STUDY POPULATION: Different ratios of Methacrylated Gelatin (GelMa), Methacrylated Alginate (AlgMa) and tricalcium phosphate (α²-TCP) were combined to optimize cell viability, GF sequestration and mechanical stability. Material characterization was performed using a rheometer to determine the viscoelastic properties of the blends. Release from disks loaded with FGF-containing PLGA microparticles was quantified with an ELISA kit. Furthermore, scanning electron microscopy (SEM) was conducted to quantify hydrogel porosity. In vitro studies were performed using NIH 3T3 murine fibroblasts in Corning Transwells while immunofluorescent, metabolic and osteogenic studies were performed in 96 well plates to investigate cell infiltration, cell adhesion, viability and differentiation, respectively. RESULTS/ANTICIPATED RESULTS: By adjusting the AlgGelMa ratio, we manipulated matrix properties. GelMa possesses excellent durability and cell adhesion due to intrinsic RGD-binding motifs. AlgMa enhanced swelling by 30%, growth factor sequestration by 50% in 24hrs, and matrix storage modulus without increasing the loss modulus which could cause cell migration away from the hydrogel. Varying the AlgGelMa ratio lowered pH, promoted cell infiltration, and reduced fibronectin accumulation. The addition of β-TCP is anticipated to improve cell differentiation towards an osteogenic lineage due to improved elastic modulus, calcium and phosphate ion concentration improving mineral deposition. DISCUSSION/SIGNIFICANCE: These findings suggest through the use of this composite, early cell infiltration can be increased and promoted due to FGF release, leading to increased osteointegration. Our porous cover-core design ensures efficient clot integration and early cell infiltration, enhancing osteointegration through FGF release.

OBJECTIVES/GOALS: Lung cancer is the leading cause of cancer-related mortality in the United States for both men and women. African Americans are disproportionately affected with lung cancer, having higher incidence and mortality rates compared to Caucasian men and women. African American smokers are diagnosed with lung cancer at a lower age with lower cumulative smoking history. Differences in socioeconomic and environmental factors likely contribute to lung cancer disparities, but less is known about acquired biologic alterations that can promote initiation and progression of lung cancer, particularly in African Americans. This is of interest because there may be other biological, genetic, or environmental factors contributing to lung cancer outcomes as it relates to differences in gender and race. One potential biologic variable may be in the DNA repair capacity (DRC), which describes a cell’s ability to repair damage to DNA caused by carcinogens, oxidants, and radiation. Altered DNA repair is a hallmark of cancer, leading to mutations and malignant transformation. We hypothesize that DRC is decreased in African Americans with lung cancer compared to Caucasian Americans with lung cancer, contributing to the disparity that exists in this racial group. We will 1) perform a retrospective chart review to determine demographic differences between African Americans and Caucasians at three central Indiana hospitals and 2) determine the impact of race and lung cancer on DRC amongst African Americans and Caucasians with and without lung cancer. METHODS/STUDY POPULATION: Lung cancer patients are identified in 3 central Indiana hospitals with different payer source and patient populations using ICD codes. Collected demographics include age, gender, pack-years, lung cancer histology, treatment, and mortality. DRC is measured by host-cell reactivation (non-homologous end-joining and nucleotide excision repair pathways) by flow-cytometry. Measurement of DRC is performed on PBMCs obtained from 120 patients (male and female, African Americans and Caucasians with and without lung cancer). Correlation of DRC and lung cancer will be determined by comparing lung cancer diagnosis to quartile DRC, and adjusted for confounders (measured demographics). Correlative measures will include measures of DNA damage and genomic instability. RESULTS/ANTICIPATED RESULTS: 3450 lung cancer patients were diagnosed with lung cancer at Indiana University Hospital between 1/1/2000 – 5/31/2015. Of these, 48.2% were female and 92.7% smokers. African Americans, Caucasians and Other ethnicities represented 12%, 86% and 2%, respectively. Of smokers, 11.4% were African American. The primary payer source was Federal/Medicare. Retrospective review of lung cancer patients from two additional health systems (county and VA hospitals) will be performed as above with outcomes measured. DRC and additional correlative measures will be performed as in Methods. DISCUSSION/SIGNIFICANCE OF IMPACT: If present, altered DRC in African Americans compared to Caucasians may contribute to the disproportional impact of lung cancer on African Americans. If DRC is decreased in African Americans with lung cancer, future studies will focus on identifying potential genetic, epigenetic and environmental causes for this decrease.

OBJECTIVES/GOALS: To examine the individual and combined association between preoperative sleep disturbance (SD) and depression and 12-month disability, back pain, and leg pain after lumbar spine surgery (LSS). METHODS/STUDY POPULATION: We analyzed prospectively collected multi-center registry data from 700 patients undergoing LSS (mean age=60.9 years, 37% female, 89% white). Preoperative SD and depression were assessed with PROMIS measures. Established thresholds defined patients with moderate/severe symptoms. Disability (Oswestry Disability Index) and back and leg pain (Numeric Rating Scales) were assessed preoperatively and at 12 months. We conducted separate regressions to examine the influence of SD and depression on each outcome. Regressions examined each factor with and without accounting for the other and in combination as a 4-level variable. Covariates included age, sex, race, education, insurance, body mass index, smoking status, preoperative opioid use, fusion status, revision status, and preoperative outcome score. RESULTS/ANTICIPATED RESULTS: One hundred thirteen (17%) patients reported moderate/severe SD alone, 70 (10%) reported moderate/severe depression alone, and 57 (8%) reported both moderate/severe SD and depression. In independent models, preoperative SD and depression were significantly associated with 12-month outcomes (all p’s<0.05). After accounting for depression, preoperative SD was only associated with disability, while preoperative depression adjusting for SD remained associated with all outcomes (all p’s<0.05). Patients reporting both moderate/severe SD and moderate/severe depression had 12.6 points higher disability (95%CI=7.4 to 17.8) and 1.5 points higher back (95%CI=0.8 to 2.3) and leg pain (95%CI=0.7 to 2.3) compared to patients with no/mild SD and no/mild depression. DISCUSSION/SIGNIFICANCE: Preoperative SD and depression are independent predictors of 12-month disability and pain when considered in isolation. The combination of SD and depression impacts postoperative outcomes considerably. The high-risk group of patients with moderate/severe SD and depression could benefit from targeted treatment strategies.

OBJECTIVES/GOALS: To investigate the relationship between abnormal bacterial colonization of the gastrointestinal (GI) tract and systemic abnormalities in innate immunity as it contributes to the pathogenesis of rosacea. METHODS/STUDY POPULATION: This is a prospective observational study of patients with erythematotelangiectatic or papulopustular rosacea. The study participants will undergo urea breath testing for Helicobacter pylori (Hp) and hydrogen-methane breath testing for small intestinal bacterial overgrowth (SIBO). Colonic microbiome analysis will be performed using 16S rRNA sequencing of fecal samples. Further, key pro-inflammatory cytokines will be quantified from serum samples. Markers for rosacea subjects and subgroups will be compared by standard analysis of variance methods where appropriate, and Tukey studentized range tests will be done for specific comparisons. Chi-square tests will be used to assess group differences in categorical data. At least 42 subjects will be studied to provide 80% power atα-0.05. RESULTS/ANTICIPATED RESULTS: We hypothesize that the results of this study will support an observed relationship between abnormal GI bacterial colonization and systemic innate immunity abnormalities in rosacea as determined by three primary endpoints: a significantly greater prevalence of Hp and SIBO in rosacea participants, presence of pro-inflammatory cytokines linked to rosacea pathogenesis including interleukin (IL)-1β, IL-6, IL-8, tumor necrosis factor (TNF)-α, and Granulocyte-macrophage colony-stimulating factor (GM-CSF), and observation of distinct, metabolically active colonic bacterial communities specific to rosacea participants. DISCUSSION/SIGNIFICANCE: By identifying rosacea as a cutaneous manifestation of a more systemic inflammatory disease, the results of this study will have implications for the development of important pharmacological interventions targeting key inflammatory pathways in rosacea pathogenesis.

OBJECTIVES/GOALS: To identify an electroencephalographic (EEG) signature of SOR in adults with TS METHODS/STUDY POPULATION: We will recruit 60 adults with CTD and 60 sex- and age-matched healthy controls to complete scales assessing severity of SOR (Sensory Gating Inventory, SGI), tics, and psychiatric symptoms. Subjects will then be monitored on dense-array scalp EEG during sequential auditory and tactile sensory gating paradigms, as such paradigms have been shown to correlate with self-report measures of SOR in other populations. Single-trial EEG data will be segmented into 100-ms epochs and spectrally deconvoluted into standard frequency bands (delta, theta, alpha, beta, gamma) for pre-defined regions of interest. We will conduct between-group contrasts (Wilcoxon rank-sum) of band-specific sensory gating indices and within-group correlations (Spearman rank correlations) between sensory gating indices and SGI scores. RESULTS/ANTICIPATED RESULTS: We hypothesize that, relative to controls, adults with CTD exhibit impaired sensory gating and that extent of impairment correlates with severity of SOR. 14 adults with CTD (9 men, 5 women) and 16 controls (10 men, 6 women) have completed the protocol to date. Within this sample, adults with CTD showed significantly reduced sensory gating compared to controls in frontal (CTD median 0.12 dB (interquartile range -0.15–0.70 dB); control -0.37 dB (-0.80–-0.13 dB); p = 0.01) and parietal (CTD 0.17 dB (-0.08–0.50 dB); control -0.20 dB (-0.43–0.10 dB); p = 0.01) gamma band during the 100-200 ms epoch in the tactile paradigm. No significant between-group differences were evident for the auditory paradigm. Among adults with CTD, multiple sensory gating indices significantly correlated with SGI scores. Enrollment continues. DISCUSSION/SIGNIFICANCE: Results aim to clarify the extent of sensory gating impairment in TS and identify a clinical correlate of neurophysiologic dysfunction in the disorder. Such knowledge has direct implications for identification of candidate neurophysiologic biomarkers, an express goal of the National Institutes of Health.

OBJECTIVES/SPECIFIC AIMS: The aim is to investigate if sustained weight loss due to caloric restriction can be achieved in a community setting, using faith-based organisations (FBOs) as hubs; and if this weight loss can lead to the re-establishment of normal metabolism (using the normalisation of blood sugar levels while off glucose lowering medication as a proxy) in a person with pre-diabetes or T2DM. METHODS/STUDY POPULATION: Members of the FBO with either a diagnosis of T2DM for <6 years or pre-diabetes as defined by the American Diabetes Association (ADA); and a Body Mass index (BMI) of ≥27 kg/m2 are eligible. After counselling, participants will be placed on a 12 week low calorie liquid diet, supplemented by low carbohydrate vegetables, totalling approximately 840 kcal/day. During this time, participants will be monitored weekly at their FBO by trained members of their congregation, with oversight from the study team, for change in weight, fasting blood glucose, waist and hip circumference and blood pressure. This will be followed by a 3 month period during which participants will receive ongoing dietary advice as they transfer to a balanced, reduced calorie, solid diet. Physical measurements will be monitored monthly during this 3 month period. The next 6 months is a period where the participants and the FBO health team move towards ‘independence’. This involves further training of the FBO health team and participants in healthy lifestyle habits; and a commitment by the leadership of the FBO to assume ‘ownership’ for NCD monitoring within their community. Physical measurements will be repeated at the end of one year. RESULTS/ANTICIPATED RESULTS: Based on previous studies, we expect that participants who are compliant to the diet will lose approximately 2.2 kg per week over the 12 week period. This will be associated with rapid (within 1 week) normalisation of fasting blood glucose levels (<7mmol / L). We expect that, due to the accessibility of NCD monitoring and support, that participants to be satisfied with their care and compliant to their regime and that the results of the first 12 weeks will be sustained at the 12 month follow up. We expect that the FBO leadership will assume the responsibility of continuing and NCD programme, not only for the local congregation but for the surrounding community. DISCUSSION/SIGNIFICANCE OF IMPACT: Diabetes remission with a low calorie diet is a viable intervention for T2DM remission however social support is key to an individual’s success. This novel study which proposes institution of a diabetes remission intervention which fits into the participant’s locale and involves peer support, should increase long-term success.