CAMPO Central Laboratory Core

用于中心实验室核心的摘要 加州-墨西哥-波多黎各(坎波)联盟将进行三项临床研究 重点关注在墨西哥和波多黎各艾滋病毒阳性妇女中预防宫颈癌。研究1 将在4000年中检查宫颈高度鳞状上皮内病变(HSIL)的新筛查算法 墨西哥和波多黎各的艾滋病毒阳性妇女。研究2将评估使用肛门益生菌对 600例HIV感染者的肛门和宫颈微生物区系及其与肛门和宫颈HSIL消退的关系 阳性的女性和男性，以及那些没有损伤的人中高危HPV DNA持久性的减少。 研究3将评估以多价复制缺陷型腺病毒为基础的安全性和有效性 治疗性HPV疫苗治疗300例HIV阳性男女宫颈和肛门HSIL 免疫应答与HSIL回归相关。与数据管理和统计核心合作， 管理和协调核心，以及临床试验计划，中央实验室核心(CLC)将 对三项研究中的每一项进行实验室分析。《中图法》的目标是：(1)开展实验室工作 为实现在园区内进行的临床研究的主要目标所需的分析 联合体的临床试验计划；(2)为相关科学研究进行实验室分析 坎波财团；(3)扩大墨西哥和波多黎各财团合作伙伴的研究能力 通过技术转让；(4)参加严格的质量控制计划，确保 实验室数据；以及(5)支持实验室早期职业研究人员的培训和职业发展- 基础研究。CLC将由印加的Alejandro Garcia-Carranca博士领导，由Filipa博士共同领导 UPR的戈多-维托里诺和加州大学旧金山分校的乔尔·帕勒夫斯基。与其他Campo核心类似，CLC将是 由三个联合体地点的调查人员和设施组成的网络，密切合作 一起，但每个站点都根据其特定的专业知识分配任务。《中图法》将拥有虚拟的 和物理组件，在印加、INSP和墨西哥的康德萨诊所拥有CLC实验室设施， 波多黎各大学综合癌症中心、波多黎各大学临床试验中心、 和加州大学旧金山分校。该网络将使用GlobalTraceTM在两个地点之间跟踪和运送实验室标本。这个 CLC将成立以Campo的科学议程为中心的工作组-HPV诊断，微生物组研究 和细胞免疫学-每个地点都有科学家的代表，并将参加夏令营 临床试验计划研究方案团队。《中图法》将执行严格的质量保证计划 定期向坎波领导报告结果。

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.