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Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers

NCT05663502 · AIDS Malignancy Consortium
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Official title
Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials
About this study
This study is collecting blood and tissue samples (biospecimens) from people living with HIV, who are participating in an AIDS Malignancy Consortium (AMC) clinical trial. Biospecimens are also collected from people who are not living with HIV, but who have a type of cancer that is common in persons living with HIV. The National Cancer Institute created the AIDS and Cancer Specimen Resource (ACSR), a place where these tissue samples are stored, so researchers can learn more about how to treat HIV and related diseases. The AMC works with the AIDS and Cancer Specimen Resource (ACSR) to collect donated samples from people living with HIV or who have cancers that are associated with HIV for future research studies. People who do not take part in an AMC clinical trial can donate samples to the ACSR. Individuals who agree to participate will be asked to donate blood once. Their blood will be stored in a biobank, and used for research. Individuals may also donate tissue - either from a previous procedure, or from an upcoming procedure.
Eligibility criteria
Inclusion Criteria: * Participants must be at least 18 years of age * Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as: * classic Kaposi sarcoma * transplant-associated Kaposi sarcoma, * anal cancer, * multicentric Castleman's disease, * Epstein Barr Virus (EBV) -positive lymphoma * plasmablastic lymphoma * Hodgkin's lymphoma. * For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: : * Documentation of HIV diagnosis in the medical record by a licensed health care provider; * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \[e.g., Truvada\], which is exclusionary); * HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating \> 1000 RNA copies/mL; * Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV Western blot confirmation or HIV rapid multispot antibody differentiation assay. * Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer. * The investigator determines that the participant (or his/her legally authorized representative \[LAR\]) has the ability to provide informed consent and the participant or LAR provides written informed consent.
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-05-10
Estimated completion: 2035-08-31
Last updated: 2025-07-17
Interventions
Procedure: Biospecimen Collection
Primary outcomes
  • Number of biospecimens collected (Through study completion, anticipated to be 10 years)
Sponsor
AIDS Malignancy Consortium · network
With: National Cancer Institute (NCI)
Contacts & investigators
InvestigatorJeff Bethony · principal_investigator, AIDS Malignancy Consortium
All locations (8)
UC San Diego Moores Cancer CenterRecruiting
La Jolla, California, United States
University of California, San FranciscoRecruiting
San Francisco, California, United States
George Washington UniversityRecruiting
Washington D.C., District of Columbia, United States
University of MiamiRecruiting
Miami, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting
Baltimore, Maryland, United States
Mount Sinai HospitalRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Huntsman Cancer Institute, University of UtahRecruiting
Salt Lake City, Utah, United States
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers · TrialPath