AIDS Malignancy Consortium (AMC)

艾滋病恶性肿瘤协会 (AMC)

• 批准号: 10167568
• 负责人: Joseph A. Sparano
• 金额: $ 14.98万
• 依托单位: MONTEFIORE MEDICAL CENTER (BRONX, NY)
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-29 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10167568
• 关键词: 2019-nCoV; AIDS Malignancy Consortium; AIDS clinical trial group; AIDS related cancer; Accountability; Acquired Immunodeficiency Syndrome; Address; Adolescent; Affect; Africa South of the Sahara; African; Anal Intraepithelial Neoplasia; Anus; Area; Behavioral; Behavioral Sciences; Biological Markers; Biology; Clinical; Clinical Data; Clinical Trials; Clinical Trials Cooperative Group; Clinical trial protocol document; Communities; Conduct Clinical Trials; Country; Decision Making; Detection; Development; Disease; Dose; Drug Kinetics; Education; Enrollment; Epidemic; Epithelial; Epithelium; Evaluation; Feces; Gastrointestinal tract structure; General Population; Grant; HIV; Hematology; High Prevalence; Human Papillomavirus; Human papilloma virus infection; Immune response; Immunologics; Incidence; Individual; Infection; International; International Aspects; Intervention; Kaposi Sarcoma; Laboratories; Laboratory Study; Leadership; Logistics; Lymphoma; Malignant Neoplasms; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Memorial Sloan-Kettering Cancer Center; Mission; Monitor; Morbidity - disease rate; National Cancer Institute; National Institute of Allergy and Infectious Disease; Natural History; Non-Hodgkin' s Lymphoma; Oncology; Outcomes Research; Participant; Pathologic; Patients; Pharmaceutical Preparations; Pharmacology; Population; Prevention; Protocols documentation; Public Health; Randomized; Randomized Clinical Trials; Research; Research Personnel; Resources; Sampling; Site; Squamous intraepithelial lesion; Strategic Planning; Structure; Supervision; Surveys; Swab; Time; Translational Research; United States National Institutes of Health; Woman; Work; antiretroviral therapy; arm; authority; cancer clinical trial; cancer prevention; cancer specimen resource; cohesion; data management; design; expectation; follow-up; genetic testing; high risk; improved; medically underserved; men; men who have sex with men; mortality; operation; outreach; pandemic disease; parent grant; prevent; protocol development; randomized controlled study; research study; screening; standard of care; statistical center; targeted cancer therapy; tumor; underserved minority; virology; working group

The parent grant of this supplement is the ANal Cancer/HSIL Outcomes Research (ANCHOR) Study, a large multi-site randomized clinical trial and protocol of the AIDS Malignancy Consortium (AMC), UM1CA121947. It is designed to determine if identification and treatment of anal high-grade squamous intraepithelial lesions (HSIL), the anal cancer precursor, is effective in reducing the incidence of anal cancer, similar to the approach currently in place to prevent cervical cancer. Anal cancer has increasing in the general population in both men and women since the 1970s. It is particularly common among people living with HIV (PLWH) and especially men who have sex with men living with HIV (MSMLWH), among whom current incidence exceed 100/100,000 per year (1). PLWH are at high risk of developing anal cancer because of a high prevalence, incidence and rate of persistence of anal HSIL and the causative agent, anal human papillomavirus (HPV) infection (2). The SARS-CoV-2 pandemic has had a dramatic effect impact on the conduct of the study, prompting all ANCHOR study sites round the country to cease screening, enrollment and follow-up of randomized participants in March, 2020. Expectations are that these activities will resume at some sites in May, 2020 with more and more sites resuming normal activity over time. However, apart from affecting normal study activities, SARS-CoV-2 may have additional relevance by impacting on the natural history of anal HPV infection, development and persistence of anal HSIL, and progression from HSIL to anal cancer. This is because of the growing body of evidence that SARS-CoV-2 is shed in stool and may infect the gastrointestinal tract. Nothing is known at present as to whether SARSCoV-2 can infect the anal epithelium specifically, whether it affects the biology of anal HPV infection, how it affects the local immune response, and whether it affects the natural history of anal HSIL. Furthermore, nothing is known about anal SARS-CoV-2 infection in the group at highest risk of anal cancer, PLWH. The ANCHOR study offers an ideal opportunity to begin to address these issues particularly since a high proportion of participants in the ANCHOR Study are from medically underserved minority populations who are also at very high risk of SARS-CoV-2 infection. The focus of this supplement is to describe detection of SARS-CoV-2 in anal swab samples from PLWH being screened for the ANCHOR study; examine its relationship to prevalent anal HPV infection and HSIL in the screening population; and determine its effect on the natural history of anal HPV infection and HSIL by examining its relationship to regression of HSIL and clearance of HPV infection in the subset of enrolled participants randomized to the active monitoring arm.

该补充剂的父授予是肛门癌/HSIL结果研究（Anchor）研究，这是一项大型多站点随机临床试验和AIDS恶性财团（AMC）的方案，UM1CA121947。它旨在确定肛门高级鳞状上皮内病变（HSIL）（肛门癌前体）是否有效降低肛门癌的发生率，类似于预防宫颈癌的方法，这是否有效。自1970年代以来，男性和女性普通人群的肛门癌一直在增加。在患有艾滋病毒（PLWH）的患者中，尤其是与患有艾滋病毒（MSMLWH）发生性关系的男性，目前每年的发病率超过100/100,000（1），这一点尤其普遍。由于肛门HSIL的患病率高，发病率和持续性，PLWH的风险很高。 SARS-COV-2大流行对研究的行为产生了巨大影响，促使全国各地的所有锚固研究地点停止筛查，入学和随访，并于2020年3月对随机参与者进行随机参与者的随访。期望这些活动将在2020年5月，更多的站点恢复更多的地点，并随着时间的推移恢复更多的正常活动。但是，除了影响正常研究活动外，SARS-COV-2可能通过影响肛门HPV感染，肛门HSIL的发育和持续性以及从HSIL到肛门癌的自然史而具有更多相关性。这是因为越来越多的证据表明SARS-COV-2在粪便中脱落并可能感染胃肠道。目前，SARSCOV-2是否可以特别感染肛门上皮，它是否影响肛门HPV感染的生物学，如何影响局部免疫反应以及它是否影响肛门HSIL的自然病史。此外，对肛门癌最高风险的该组中的肛门SARS-COV-2感染一无所知。锚研究提供了一个理想的机会开始解决这些问题，尤其是因为锚固研究的参与者很大一部分来自医疗服务不足的少数民族，他们也处于SARS-COV-2感染的高风险。该补充剂的重点是描述从PLWH中筛选肛门拭子样品中SARS-COV-2的检测；检查其与筛查人群中普遍的肛门HPV感染和HSIL的关系；并通过检查其与HSIL的回归和HPV感染的回归的关系来确定其对肛门HPV感染和HSIL自然史的影响。