Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials
3 other identifiers
observational
200
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2022
CompletedFirst Posted
Study publicly available on registry
December 23, 2022
CompletedStudy Start
First participant enrolled
May 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2035
July 17, 2025
July 1, 2025
7.3 years
December 15, 2022
July 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of biospecimens collected
The number of blood and tissue specimens will be counted.
Through study completion, anticipated to be 10 years
Study Arms (1)
Observational (biospecimen collection)
Patients undergo collection of fresh blood and/or tumor tissue samples
Interventions
Undergo blood and/or tumor tissue sample collection
Eligibility Criteria
Study population includes patients with human immunodeficiency virus (HIV) infection and HIV-associated malignancies, as well as HIV-negative cancer patients.
You may qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AIDS Malignancy Consortiumlead
- National Cancer Institute (NCI)collaborator
Study Sites (8)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
University of California, San Francisco
San Francisco, California, 94110, United States
George Washington University
Washington D.C., District of Columbia, 20052, United States
University of Miami
Miami, Florida, 33136, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21774, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Bethony
AIDS Malignancy Consortium
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2022
First Posted
December 23, 2022
Study Start
May 10, 2023
Primary Completion (Estimated)
August 31, 2030
Study Completion (Estimated)
August 31, 2035
Last Updated
July 17, 2025
Record last verified: 2025-07