CAMPO Central Laboratory Core

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ABSTRACT FOR THE CENTRAL LABORATORY CORE The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV- positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. Working with the Data Management and Statistics Core, the Administrative and Coordinating Core, and the Clinical Trials Program, the Central Laboratory Core (CLC) will perform laboratory assays for each of the three studies. The aims of the CLC are: (1) To perform laboratory assays required to achieve the primary aims of the clinical research studies conducted within the CAMPO Consortium’s Clinical Trials Program; (2) To perform laboratory assays for correlative science studies for the CAMPO Consortium; (3) To expand research capacity of consortium partners in Mexico and Puerto Rico through technology transfer; (4) To participate in rigorous quality control programs to ensure the validity of laboratory data; and (5) To support training and career development of early career investigators in laboratory- based research. The CLC will be led by Dr. Alejandro Garcia-Carranca of INCan and co-led by Drs. Filipa Godoy-Vitorino of UPR and Joel Palefsky of UCSF. Similar to the other CAMPO Cores, the CLC will be comprised of a network of investigators and facilities across the three Consortium sites, working closely together but with each site tasked with a role based on their specific expertise. The CLC will have both virtual and physical components, with CLC laboratory facilities at INCan, INSP and the Condesa Clinic in Mexico, the University of Puerto Rico Comprehensive Cancer Center, the University of Puerto Rico Clinical Trials Center, and UCSF. The network will use GlobalTraceTM to track and ship laboratory specimens between the sites. The CLC will form working groups centered on CAMPO’s scientific agenda- HPV diagnostics, microbiome research and cellular immunology- with representation from scientists at each site and will participate on CAMPO Clinical Trials Program study protocol teams. The CLC will perform a rigorous quality assurance program and report results on a regular basis to CAMPO leadership.