ClinicalTrials.gov record NCT05663502

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects and stores blood and tumor tissue donations for research on HIV-associated cancers. It is open to adults with HIV and a diagnosed malignancy, and to HIV-negative adults with cancers linked to HIV. Participants will typically give one blood sample and may donate tissue from a past or planned procedure.

What it is studying. Collects and stores blood and tissue specimens to make them available to researchers studying biological and genetic features of HIV-related cancers.

What the researchers hope to learn. To build a biobank of blood and tumor tissue from people with HIV and related cancers. To enable laboratory studies of biomarkers and biological or genetic factors associated with these cancers. To count and catalog specimens for future research use.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure
  • Biospecimen Collection

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

You will be asked to donate blood once; the blood will be stored in a biobank for research. You may also donate tissue either from a previous procedure or from an upcoming procedure. Samples will be stored with the AIDS and Cancer Specimen Resource (ACSR) and used for future laboratory research. You (or your legally authorized representative) must sign written informed consent to participate.

How the study is structured. An observational, case-only, cross-sectional collection: participants provide biospecimens (one-time blood draw and optional tumor tissue from prior or planned procedures). Samples are stored in the AIDS and Cancer Specimen Resource (ACSR) for future laboratory research; there is no study treatment assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Castleman disease

Clinical trials14 trials listed for Castleman diseaseEvery trial the registry lists for Castleman disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Castleman disease researchLatest monthly update: September 2026. Includes: Unicentric tumor removal. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 10, 2023
Primary completion
Aug 31, 2030 (estimated)
Study completion
Aug 31, 2035 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
Jun 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
AIDS Malignancy Consortium
Collaborators
  • National Cancer Institute (NCI)

Participating sites (8)

  • UC San Diego Moores Cancer CenterRecruiting

    La Jolla, California, 92093 · United States

  • University of California, San FranciscoRecruiting

    San Francisco, California, 94110 · United States

  • George Washington UniversityRecruiting

    Washington D.C., District of Columbia, 20052 · United States

  • University of MiamiRecruiting

    Miami, Florida, 33136 · United States

  • Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting

    Baltimore, Maryland, 21774 · United States

  • Mount Sinai HospitalRecruiting

    New York, New York, 10029 · United States

  • Memorial Sloan Kettering Cancer CenterRecruiting

    New York, New York, 10065 · United States

  • Huntsman Cancer Institute, University of UtahRecruiting

    Salt Lake City, Utah, 84112 · United States

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
clinical trial
A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
legally authorized representative
A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
biospecimens
A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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