Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
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 biologic or genetic factors are related to HIV and cancers that occur commonly in people living with HIV.
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 * 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 * NOTE: A “licensed” assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all investigational new drug (IND) studies
- Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer or a condition that places them at a higher risk of cancer * NOTE: Participants are not required to enroll in an AMC treatment trial to be considered eligible
- 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
Exclusion Criteria
- Donors who do not fulfill the criteria as listed above are ineligible
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05663502.
Locations matching your search criteria
United States
California
La Jolla
San Francisco
District of Columbia
Washington
Florida
Miami
Maryland
Baltimore
Missouri
Saint Louis
New Jersey
Basking Ridge
Middletown
Montvale
New York
Commack
New York
Uniondale
West Harrison
Utah
Farmington
Salt Lake City
PRIMARY OBJECTIVE:
I. To define the mechanisms for AIDS Malignancy Consortium (AMC) member sites to obtain biospecimens and associated clinical information from potential AMC clinical trial participants for AIDS and Cancer Specimen Resource (ACSR) donation.
OUTLINE: This is an observational study.
Patients undergo collection of blood and/or existing tumor tissue samples for biospecimen banking on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationAIDS Malignancy Consortium
Principal InvestigatorJeffrey M Bethony
- Primary IDAMC-S005
- Secondary IDsNCI-2021-05722
- ClinicalTrials.gov IDNCT05663502