Clinical trial NCT05663502: Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
Official title: Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): a Companion Protocol to AMC Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of biospecimens collected
timeFrame: Through study completion, anticipated to be 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: District of columbia
country: United States
facility: George Washington University
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
Study officials:
affiliation: AIDS Malignancy Consortium
name: Jeff Bethony
role: PRINCIPAL_INVESTIGATOR
References: