Collecting blood and tissue samples for HIV/AIDS-related cancer research

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Jeff Bethony — AIDS Malignancy Consortium

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.