RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-10
Study Completion:2035-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05663502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be at least 18 years of age
  2. * 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:
  3. * classic Kaposi sarcoma
  4. * transplant-associated Kaposi sarcoma,
  5. * anal cancer,
  6. * multicentric Castleman's disease,
  7. * Epstein Barr Virus (EBV) -positive lymphoma
  8. * plasmablastic lymphoma
  9. * Hodgkin's lymphoma.
  10. * For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: :
  11. * Documentation of HIV diagnosis in the medical record by a licensed health care provider;
  12. * 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);
  13. * HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating \> 1000 RNA copies/mL;
  14. * 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.
  15. * 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.
  16. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Jeff Bethony
PRINCIPAL_INVESTIGATOR
AIDS Malignancy Consortium

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94110
United States
George Washington University
Washington, District of Columbia, 20052
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21774
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: AIDS Malignancy Consortium

  • Jeff Bethony, PRINCIPAL_INVESTIGATOR, AIDS Malignancy Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10
Study Completion Date2035-08-31

Study Record Updates

Study Start Date2023-05-10
Study Completion Date2035-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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