ClinicalTrials.gg
RecruitingNCT05663502Updated Jun 1, 2026

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

An observational study in Anal Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm and HIV Infection, sponsored by AIDS Malignancy Consortium. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by AIDS Malignancy Consortium · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • 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
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In context

Anus Neoplasms

297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.

This study's planned enrollment of 200 is above the median of 144 across 75 observational studies indexed under Anus Neoplasms.

Browse Anus Neoplasms studies →

Lead sponsor

AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 9 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 9 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population includes patients with human immunodeficiency virus (HIV) infection and HIV-associated malignancies, as well as HIV-negative cancer patients.

Eligibility criteria

Inclusion Criteria:

  • Participants must be at least 18 years of age
  • Participant must be - positive and have a diagnosed . 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 and the participant or LAR provides written informed consent.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)

Groups and cohorts

  • Observational (biospecimen collection)

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

    Procedure: Biospecimen Collection

Interventions

  • ProcedureBiospecimen Collection

    Undergo blood and/or tumor tissue sample collection

    Also known as: Biological Sample Collection

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What researchers measure

Primary outcomes

  1. Number of biospecimens collected

    The number of blood and tissue specimens will be counted.

    Time frame: Through study completion, anticipated to be 10 years

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Study locations

8 of 8 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05663502
Lead sponsor
AIDS Malignancy Consortium
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
May 10, 2023
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2035 (estimated)
Last update
Jun 1, 2026

Study contacts

Jeff Bethony
principal investigator · AIDS Malignancy Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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