Collecting blood and tissue samples for HIV/AIDS-related cancer research
Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials
This study is collecting blood and tissue samples from people living with HIV and related cancers to help researchers learn more about how HIV affects cancer development.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AIDS Malignancy Consortium Research network |
| Locations | 8 sites (La Jolla, California and 7 other locations) |
| Trial ID | NCT05663502 on ClinicalTrials.gov |
What this trial studies
This study collects blood and tissue samples from individuals living with HIV and those with cancers commonly associated with HIV. Participants will donate blood once, and tissue samples may be collected from previous or upcoming medical procedures. The samples will be stored in a biobank for future research aimed at understanding the biological and genetic factors linking HIV to specific cancers. The study is part of the AIDS Malignancy Consortium's efforts to enhance knowledge and treatment options for HIV-related malignancies.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older who are HIV-positive with a diagnosed malignancy or HIV-negative individuals with cancers linked to HIV.
Not a fit: Patients without HIV or those with malignancies not associated with HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment of HIV/AIDS-related cancers.
How similar studies have performed: Other studies have successfully utilized biospecimen collection to advance research in HIV-related cancers, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California and 7 other locations
- UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- George Washington University — Washington D.C., District of Columbia, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Jeff Bethony — AIDS Malignancy Consortium
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.