Anal CarcinomaNCT05663502
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
An observational study of Anal Carcinoma and Hematopoietic and Lymphoid Cell Neoplasm, run by AIDS Malignancy Consortium at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 May 2023to 31 Aug 2035
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population includes patients with human immunodeficiency virus (HIV) infection and HIV-associated malignancies, as well as HIV-negative cancer patients.
Who may be able to join
- 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,
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- 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.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21774
Laura Clark, 410-502-5396, lclark53@jhmi.edu
Richard Ambinder, MD
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Erin Reid, MD, 858-822-5354, cancercto@ucsd.edu
Erin Reid, MD
- Recruiting
University of Miami
Miami, Florida, 33136
Helen Kattoura, 305-243-6438, hkattoura@miami.edu
Juan C Ramos, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Keith Sigel, MD, 212-825-7558, keith.sigel@mssm.edu
Keith Sigel, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ariela Noy, MD, 646-608-3727, noya@mskcc.org
Ariela Noy, MD
- Recruiting
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Gayatri Nachaegari, 801-213-4329, gayatri.nachaegari@hci.utah.edu
Gita Suneja, MD, MSHP
- Recruiting
University of California, San Francisco
San Francisco, California, 94110
Ivan Leung, 628-206-7748, ivan.leung@ucsf.edu
Chia-Ching (Jackie) Wang, MD
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20052
Lakeisha McCormick, 202-994-0872, lmccorm@gwu.edu
Sharad Goyal, MD
About this study
Official title: Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials
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.
- Conditions
- Anal Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, HIV Infection, Kaposi Sarcoma, Lymphoma, Malignant Solid Neoplasm
- Being tested
- Biospecimen Collection
- Medical subject headings
- Anus Neoplasms, Hematologic Neoplasms, HIV Infections, Sarcoma, Kaposi, Lymphoma, Multi-centric Castleman's Disease, Plasmablastic Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood and/or tumor tissue sample collection
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen collection) | Patients undergo collection of fresh blood and/or tumor tissue samples Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biospecimens collected
The number of blood and tissue specimens will be counted.
Measured: Through study completion, anticipated to be 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start10 May 2023
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeff Bethony, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663502
- Sponsor's protocol ID
- AMC-S005
- Other IDs
- NCI-2021-05722, AMC-S005, AMC-S005, UM1CA121947
- Status last verified
- May 2026
- First submitted
- 15 Dec 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes