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

NCT ID: NCT05663502

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-10

Study Completion Date

2035-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is collecting blood and tissue samples (biospecimens) from people living with HIV, who are participating in an AIDS Malignancy Consortium (AMC) clinical trial. Biospecimens are also collected from people who are not living with HIV, but who have a type of cancer that is common in persons living with HIV. The National Cancer Institute created the AIDS and Cancer Specimen Resource (ACSR), a place where these tissue samples are stored, so researchers can learn more about how to treat HIV and related diseases. The AMC works with the AIDS and Cancer Specimen Resource (ACSR) to collect donated samples from people living with HIV or who have cancers that are associated with HIV for future research studies. People who do not take part in an AMC clinical trial can donate samples to the ACSR.

Individuals who agree to participate will be asked to donate blood once. Their blood will be stored in a biobank, and used for research. Individuals may also donate tissue - either from a previous procedure, or from an upcoming procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anal Carcinoma Hematopoietic and Lymphoid Cell Neoplasm HIV Infection Kaposi Sarcoma Lymphoma Malignant Solid Neoplasm Multicentric Castleman Disease Plasmablastic Lymphoma Recurrent Kaposi Sarcoma Recurrent Lymphoma Recurrent Plasmablastic Lymphoma Transplant-Related Kaposi Sarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Observational (biospecimen collection)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and/or tumor tissue sample collection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo blood and/or tumor tissue sample collection

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

AIDS Malignancy Consortium

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeff Bethony

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

George Washington University

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

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Erin Reid, MD

Role: primary

858-822-5354

Ivan Leung

Role: primary

628-206-7748

Lakeisha McCormick

Role: primary

202-994-0872

Helen Kattoura

Role: primary

305-243-6438

Laura Clark

Role: primary

410-502-5396

Keith Sigel, MD

Role: primary

212-825-7558

Ariela Noy, MD

Role: primary

646-608-3727

Gayatri Nachaegari

Role: primary

801-213-4329

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2021-05722

Identifier Type: REGISTRY

Identifier Source: secondary_id

AMC-S005

Identifier Type: OTHER

Identifier Source: secondary_id

AMC-S005

Identifier Type: OTHER

Identifier Source: secondary_id

UM1CA121947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AMC-S005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.