Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
NCT ID: NCT05663502
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2023-05-10
2035-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Observational (biospecimen collection)
Patients undergo collection of fresh blood and/or tumor tissue samples
Biospecimen Collection
Undergo blood and/or tumor tissue sample collection
Interventions
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Biospecimen Collection
Undergo blood and/or tumor tissue sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Jeff Bethony
Role: PRINCIPAL_INVESTIGATOR
AIDS Malignancy Consortium
Locations
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UC San Diego Moores Cancer Center
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
George Washington University
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Mount Sinai Hospital
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2021-05722
Identifier Type: REGISTRY
Identifier Source: secondary_id
AMC-S005
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-S005
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-S005
Identifier Type: -
Identifier Source: org_study_id
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