CAMPO Central Laboratory Core

CAMPO 中心实验室核心

• 批准号: 10226227
• 负责人: Teresa Marie Darragh
• 金额: $ 34.93万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-12 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10226227
• 关键词: Adenoviruses; Algorithms; Anus; Biological Assay; Biopsy; California; Cellular Immunology; Cervical; Clinic; Clinical; Clinical Research; Clinical Trials; Comprehensive Cancer Center; DNA; Data; Diagnostic; Disease; Disease regression; Ensure; Grant; HIV; HIV Seropositivity; HPV-High Risk; Human Papilloma Virus-Related Malignant Neoplasm; Human Papillomavirus; Human papilloma virus infection; Immune response; Laboratories; Leadership; Lesion; Malignant Neoplasms; Measures; Mentorship; Mexico; Participant; Pathology; Population; Prevention; Probiotics; Procedures; Protocols documentation; Puerto Rico; Quality Control; Reporting; Research; Research Personnel; Risk; Role; Safety; Sampling; Science; Scientist; Ships; Site; Specimen; Squamous intraepithelial lesion; Techniques; Technology Transfer; Testing; Training Programs; Training Support; Universities; Woman; Work; base; career; career development; cell mediated immune response; cervical cancer prevention; data management; disorder prevention; equipment training; high risk; laboratory facility; men; microbiome analysis; microbiome research; microbiota profiles; primary outcome; programs; quality assurance; research study; screening; statistics; therapeutic HPV vaccinations; therapeutic HPV vaccine; therapeutic vaccine; vaccine trial; virtual; working group

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.

中心实验室核心摘要 加利福尼亚-墨西哥-波多黎各（CAMPO）联盟将进行三项临床研究 重点是在墨西哥和波多黎各预防艾滋病毒阳性妇女的宫颈癌。研究1 将在4000年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将评估肛门生殖器益生菌使用对 肛门和宫颈微生物群特征以及与600例HIV感染者肛门和宫颈HSIL消退的关系- 阳性的女性和男性以及没有病变的人中高危HPV DNA持续性的降低。 研究3将评估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名HIV阳性女性和男性的宫颈和肛门HSIL， 免疫应答与HSIL消退相关。与数据管理和统计核心一起工作， 管理和协调中心以及临床试验项目中心实验室中心（CLC）将 对三项研究中的每一项进行实验室测定。CLC的目标是：（1）进行实验室 实现在CAMPO内进行的临床研究的主要目的所需的测定 （2）为临床试验项目的相关科学研究进行实验室检测， CAMPO联合体;（3）扩大墨西哥和波多黎各联合体伙伴的研究能力 通过技术转让;（4）参与严格的质量控制计划，以确保 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- 基于研究。CLC将由INCan的Alejandro Garcia-Carranca博士领导，并由Filipa博士共同领导 UPR的Godoy-Vitorino和UCSF的Joel Palefsky。与其他CAMPO核心类似，CLC将 由三个财团地点的调查人员和设施组成的网络， 但是每个站点都根据其具体的专业知识承担一个角色。CLC将同时提供虚拟 和物理成分，与CLC实验室设施在INCan，INSP和Condesa诊所在墨西哥， 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UCSF该网络将使用GlobalTraceTM在各研究中心之间跟踪和运送实验室标本。的 CLC将组建以CAMPO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-与代表的科学家在每个网站，并将参加CAMPO 临床试验项目研究方案团队。CLC将执行严格的质量保证计划， 定期向CAMPO领导层报告结果。