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Principal Investigator: Joseph A. Sparano
Organization: MONTEFIORE MEDICAL CENTER (BRONX, NY)
Fiscal Year: 2020
Award: $149,833
Funding agency: National Cancer Institute
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.
Terms: <2019 novel coronavirus><2019-nCoV><AACTG><ACTG><AIDS><AIDS Malignancy Consortium><AIDS Virus><AIDS associated cancer><AIDS clinical trial group><AIDS related cancer><AIDS-Related Malignancy><AIDS-Related Malignant Neoplasm><AIDS-associated malignancies><Accountability><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immuno-Deficiency Syndrome><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Acquired Immunologic Deficiency Syndrome><Active Follow-up><Address><Adolescent><Adolescent Youth><Affect><Africa South of the Sahara><African><Alimentary Canal><Anal><Anal Cancer><Anal Cancers><Anal Intraepithelial Neoplasia><Anus><Anus Cancer><Area><Behavioral><Behavioral Sciences><Biological Markers><Biology><Cancers><Cervical Cancer><Cervix Cancer><Clinical><Clinical Cooperative Groups><Clinical Data><Clinical Trial Groups><Clinical Trial Protocol><Clinical Trials><Clinical Trials Cooperative Group><Clinical trial protocol document><Communities><Conduct Clinical Trials><Country><Decision Making><Detection><Development><Digestive Tract><Disease><Disorder><Dose><Drug Kinetics><Drugs><Education><Educational aspects><Enrollment><Epidemic><Epithelial><Epithelium><Epithelium Part><Evaluation><Feces><Foreign Component><Foreign Subpart><Foreign or Foreign Component><GI Tract><Gastrointestinal Tract><Gastrointestinal tract structure><General Population><General Public><Germinoblastic Sarcoma><Germinoblastoma><Grant><HIV><HIV-Associated Cancer><HIV-associated malignancy><HIV-related malignancy><HIV/AIDS-associated malignancy><HIV/AIDS-related cancer><HPV><HPV infection><Hematology><High Prevalence><Human Immunodeficiency Viruses><Human Papilloma Virus><Human Papillomavirus><Human papilloma virus infection><Human papillomavirus infection><Immune response><Immunochemical Immunologic><Immunologic><Immunological><Immunological response><Immunologically><Immunologics><Incidence><Individual><Infection><Infectious Human Wart Virus><International><International Activity><International Affairs><International Aspects><Intervention><Intervention Strategies><Investigators><Kaposi Sarcoma><Kaposi's Sarcoma><LAV-HTLV-III><Laboratories><Laboratory Study><Leadership><Logistics><Lymphadenopathy-Associated Virus><Lymphoma><MSKCC><MSM><Malignant Anal Neoplasm><Malignant Anal Tumor><Malignant Cervical Neoplasm><Malignant Cervical Tumor><Malignant Lymphoma><Malignant Neoplasm of the Cervix><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Anus><Malignant Tumor of the Cervix><Malignant Tumor of the Cervix Uteri><Malignant Uterine Cervix Neoplasm><Malignant Uterine Cervix Tumor><Malignant neoplasm of anus><Malignant neoplasm of cervix uteri><Medication><Memorial Sloan-Kettering Cancer Center><Mission><Monitor><Morbidity><Morbidity - disease rate><Multinational Aspects><Multiple Hemorrhagic Sarcoma><NCI Organization><NIAID><NIH><National Cancer Institute><National Institute of Allergy and Infectious Disease><National Institutes of Health><Natural History><Non-Hodgkin's Lymphoma><Nonhodgkins Lymphoma><Oncology><Oncology Cancer><Outcomes Research><Participant><Pathologic><Patients><Pharmaceutic Preparations><Pharmaceutical Preparations><Pharmacokinetics><Pharmacology><Population><Prevention><Protocol><Protocols documentation><Public Health><Randomized><Randomized Clinical Trials><Research><Research Personnel><Research Resources><Researchers><Resources><Reticulolymphosarcoma><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Sampling><Severe acute respiratory syndrome coronavirus 2><Site><Squamous Cell Intraepithelial Neoplasia><Squamous intraepithelial lesion><Strategic Planning><Structure><Sub-Saharan Africa><Subsaharan Africa><Supervision><Survey Instrument><Surveys><Swab><Time><Translational Research><Translational Science><United States National Institutes of Health><Uterine Cervix Cancer><Virus-HIV><Woman><Work><Wuhan coronavirus><acquired immunodeficiency syndrome clinical trial group><active followup><alimentary tract><anti-retroviral therapy><anti-retroviral treatment><antiretroviral therapy><antiretroviral treatment><anus intraepithelial neoplasia><arm><authority><bio-markers><biologic marker><biomarker><cancer clinical trial><cancer prevention><cancer specimen resource><cohesion><data management><design><designing><developmental><digestive canal><drug/agent><enroll><expectation><follow up><follow-up><followed up><followup><gene testing><gene-based testing><genetic testing><high risk><host response><immunoresponse><improved><interventional strategy><juvenile><juvenile human><malignancy><medically underserved><men><men who have sex with men><men who have sex with other men><men's><mortality><neoplasm/cancer><non-Hodgkins disease><oncology clinical trial><operation><outreach><pandemic><pandemic disease><parent grant><prevent><preventing><protocol development><randomisation><randomization><randomized controlled study><randomly assigned><research study><screening><standard of care><statistical center><stool><targeted cancer therapy><translation research><tumor><underserved minority><virology><wart virus><work group><working group>