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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663502
• Other study ID #: AMC-S005
• Secondary ID: NCI-2021-05722AM
• Status: Recruiting
• Start date: May 10, 2023
• Est. completion date: August 31, 2035

Study information

• Verified date: October 2023
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 cancers that occur commonly in people living with HIV.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2035
• Est. primary completion date: August 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Carcinoma
• Castleman Disease
• Hematopoietic and Lymphoid Cell Neoplasm
• HIV Infection
• Kaposi Sarcoma
• Lymphoma
• Lymphoma, Large-Cell, Immunoblastic
• Malignant Solid Neoplasm
• Multicentric Castleman Disease
• Neoplasms
• Plasmablastic Lymphoma
• Recurrence
• Recurrent Kaposi Sarcoma
• Recurrent Lymphoma
• Sarcoma
• Sarcoma, Kaposi

Intervention

Procedure:
• Biospecimen Collection
Undergo blood and/or tumor tissue sample collection

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	George Washington University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of biospecimens collected	The number of blood and tissue specimens will be counted.	Through study completion, anticipated to be 10 years