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Protocol for Biospecimen Collection and Analysis Within the BACPAC Research Program.

ABSTRACT: The Biospecimen Collection and Processing Working Group of the National Institutes of Health (NIH) HEAL Initiative BACPAC Research Program was charged with identifying molecular biomarkers of interest to chronic low back pain (cLBP). Having identified biomarkers of interest, the Working Group worked with the New York University Grossman School of Medicine, Center for Biospecimen Research and Development-funded by the Early Phase Pain Investigation Clinical Network Data Coordinating Center-to harmonize consortium-wide and site-specific efforts for biospecimen collection and analysis. Biospecimen collected are saliva, blood (whole, plasma, serum), urine, stool, and spine tissue (paraspinal muscle, ligamentum flavum, vertebral bone, facet cartilage, disc endplate, annulus fibrosus, or nucleus pulposus). The omics data acquisition and analyses derived from the biospecimen include genomics and epigenetics from DNA, proteomics from protein, transcriptomics from RNA, and microbiomics from 16S rRNA. These analyses contribute to the overarching goal of BACPAC to phenotype cLBP and will guide future efforts for precision medicine treatment.

SUBMITTER: Fields AJ

PROVIDER: S-EPMC10403310 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Protocol for Biospecimen Collection and Analysis Within the BACPAC Research Program.

Fields Aaron J AJ Dudli Stefan S Schrepf Andrew A Kim Angie A Pham Bernice B Gallego Estefania E Mendoza Sandra S Meropol Sharon B SB Darwin Jessa J Sowa Gwendolyn G Vo Nam V NV

Pain medicine (Malden, Mass.) 20230801 Suppl 1

The Biospecimen Collection and Processing Working Group of the National Institutes of Health (NIH) HEAL Initiative BACPAC Research Program was charged with identifying molecular biomarkers of interest to chronic low back pain (cLBP). Having identified biomarkers of interest, the Working Group worked with the New York University Grossman School of Medicine, Center for Biospecimen Research and Development-funded by the Early Phase Pain Investigation Clinical Network Data Coordinating Center-to har ...[more]

PMID: 36525387

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Project description:Background and Aims: The Genomics Working Group (of the Cancer Research Network (CRN) Pharmacovigilance Project) explored single-site experiences with genomic studies to understand challenges and opportunities for collecting and using biological specimens. Its specific aims were to:Methods: We distributed a survey on existing biospecimen availability to principal investigators at all CRN Pharmacovigilance sites. Information collected included the number of specimens, storage methods, and type of specimens available. Investigators were also asked to identify past and current studies at their institutions in order to collect information on successful specimen collection strategies. A literature review was conducted both to identify potential barriers to participation and to understand the feasibility of various recruitment procedures. Benefits and limitations of ?opt-out? and ?opt-in? specimen collection methods were examined. Lastly, we developed study documents, including recruitment letters and informed consent forms, for future saliva and blood specimen collection efforts.Results: Two of the CRN HMOs currently have large-scale banked blood or saliva specimens (>20,000) within existing repositories. One site has two large-scale studies (>20,000 participants each) with banked specimens able to provide DNA for future research. Whole blood or blood components are the most commonly collected specimen types, and multiple CRN sites have access to banked tumor blocks. There were 33 past or current studies that included biospecimen collection. There was a trade-off between intensive data collection requirements and recruitment yield, cost, and participation burden.Conclusions: There is great potential for collection, storage, and use of biospecimen samples for research within the CRN. For future collection efforts, ?opt-out? models allow fast sample accrual, but impact data de-identification requirements. ?Opt-in? models allow for broad data collection, but are resource and time intensive. Pathology time and support may be a barrier to future use of stored samples.

Project description:BackgroundChronic low back pain (cLBP) is a complex with a heterogenous clinical presentation. A better understanding of the factors that contribute to cLBP is needed for accurate diagnosis, optimal treatment, and identification of mechanistic targets for new therapies. The Back Pain Consortium (BACPAC) Research Program provides a unique opportunity in this regard, as it will generate large clinical datasets, including a diverse set of harmonized measurements. The Theoretical Model Working Group was established to guide BACPAC research and to organize new knowledge within a mechanistic framework. This article summarizes the initial work of the Theoretical Model Working Group. It includes a three-stage integration of expert opinion and an umbrella literature review of factors that affect cLBP severity and chronicity.MethodsDuring Stage 1, experts from across BACPAC established a taxonomy for risk and prognostic factors (RPFs) and preliminary graphical depictions. During Stage 2, a separate team conducted a literature review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to establish working definitions, associated data elements, and overall strength of evidence for identified RPFs. These were subsequently integrated with expert opinion during Stage 3.ResultsThe majority (∼80%) of RPFs had little strength-of-evidence confidence, whereas seven factors had substantial confidence for either a positive association with cLBP (pain-related anxiety, serum C-reactive protein, diabetes, and anticipatory/compensatory postural adjustments) or no association with cLBP (serum interleukin 1-beta / interleukin 6, transversus muscle morphology/activity, and quantitative sensory testing).ConclusionThis theoretical perspective will evolve over time as BACPAC investigators link empirical results to theory, challenge current ideas of the biopsychosocial model, and use a systems approach to develop tools and algorithms that disentangle the dynamic interactions among cLBP factors.

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Protocol for Biospecimen Collection and Analysis Within the BACPAC Research Program.

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Protocol for Biospecimen Collection and Analysis Within the BACPAC Research Program.

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