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Biospecimen Collection Core: Leveraging existing and prospectively collecting specimens in a diverse cohort

$1,587,656U54FY2025AGNIH

Broad Institute, Inc., Cambridge MA

Investigators

Abstract

Project Summary- Biospecimen Collection Core The Biospecimen Collection Core (BCC) will provide biospecimens and phenotypic data from five nationwide longitudinal cohort studies that share a common study design, collectively encompassing >350,000 participants: the Nurses' Health Studies I, II, and 3, the Health Professionals Follow-Up Study, and the Growing Up Today Study. The cohorts have collected blood, urine, and stool samples repeatedly, as well as oral swab samples from a large proportion of the participants, resulting in a repository of 3.2 million biospecimens. Additionally, we will leverage post-mortem brain tissue donations and the decades-long, comprehensive collections of data on phenotypes, lifestyles, biomarkers, and multiple ‘omics in these cohorts. The BCC represents the culmination of highly successful collaborations in large-scale human biospecimen collection and data generation over more than a decade that involve three entities: Brigham and Women's Hospital/Harvard Cohorts Biorepository, Harvard Chan Microbiome in Public Health Center, and Broad Institute of Harvard and MIT. This collaboration has resulted in an integrated system for sample collection, tracking, handling, barcoding automation and a Laboratory Information Management System. The BCC will utilize existing biospecimens from four anatomic sites (blood, urine, stool and oral samples) and prospectively collect new biospecimens from seven anatomical sites (blood, urine, stool, oral, nasal, skin, and vaginal samples) in 4,000 healthy participants of varying ages (19 to 100 years), both sex/gender (65% women), geographic origin (10 standard federal regions), and racial/ethnic diversity (Black and Hispanic participants: 17%). The 4,000 participants collectively form the Virome Characterization Center (VCC) study cohort. In addition, we will collect biospecimens at up to seven time points during a week in a sub-cohort of 100 participants. The overarching goal of the BCC is to ensure the high-quality, consistent, and efficient collection, handling, management, and sharing of biospecimens and phenotypic data for human virome profiling. Aim 1 focuses on establishing a diverse VCC study cohort, obtaining informed consent allowing for unrestricted sharing of data for research purposes, and retrieving stored biospecimens and collection protocols. We will develop biospecimen collection protocols and prospectively collect samples and phenotypic and anatomical data in Aim 2. We will collaborate with the Human Virome Program (HVP) Steering Committee, other VCCs, and Cores to establish harmonized protocols, conduct sample quality evaluations, and process biospecimens (Aim 3). In Aim 4, we will ensure that biospecimens are stored, curated, and readily accessible and sharing of biospecimens and phenotypic data. This proposed study offers unparalleled opportunities to investigate the factors influencing the virome and host dynamics, as well as intra- and inter-individual variations and temporal dynamics. Upon successful completion of its specific aims, the BCC will significantly contribute to the HVP Consortium's success and advance the comprehensive characterization of eukaryotic and prokaryotic viruses in humans.

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