Recruiting

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

Sponsor:

AIDS Malignancy Consortium

Code:

NCT05663502

Conditions

Anal Carcinoma

Hematopoietic and Lymphoid Cell Neoplasm

HIV Infection

Kaposi Sarcoma

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Study Details

Brief summary:

This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.

Conditions

Anal Carcinoma

Hematopoietic and Lymphoid Cell Neoplasm

HIV Infection

Kaposi Sarcoma

Lymphoma

Study ID

NCT05663502

Start date

May 10, 2023

Status verified date

May, 2026

Completion date

Aug 31, 2035

Anticipated

Primary completion date

Aug 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection)

Patients undergo collection of fresh blood and/or tumor tissue samples

Interventions

Biospecimen Collection

Undergo blood and/or tumor tissue sample collection

Primary outcome measure

Number of biospecimens collected [ Time Frame: Through study completion, anticipated to be 10 years ]

Central Contacts and Locations

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Erin Reid, MD

858-822-5354 cancercto@ucsd.edu

Principal Investigator:

Erin Reid, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Ivan Leung

628-206-7748 ivan.leung@ucsf.edu

Principal Investigator:

Chia-Ching (Jackie) Wang, MD

George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20052

Contacts

Lakeisha McCormick

202-994-0872 lmccorm@gwu.edu

Principal Investigator:

Sharad Goyal, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Helen Kattoura

305-243-6438 hkattoura@miami.edu

Principal Investigator:

Juan C Ramos, MD

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21774

Contacts

Laura Clark

410-502-5396 lclark53@jhmi.edu

Principal Investigator:

Richard Ambinder, MD

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Keith Sigel, MD

212-825-7558 keith.sigel@mssm.edu

Principal Investigator:

Keith Sigel, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Ariela Noy, MD

646-608-3727 noya@mskcc.org

Principal Investigator:

Ariela Noy, MD

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Gayatri Nachaegari

801-213-4329 gayatri.nachaegari@hci.utah.edu

Principal Investigator:

Gita Suneja, MD, MSHP

More Information

Sponsor

AIDS Malignancy Consortium

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AIDS Malignancy Consortium on 2026-06-01.