Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Chia-Ching (Jackie) Wang, MD
Headshot of Chia-Ching (Jackie) Wang
Chia-Ching (Jackie) Wang

Description

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.

Official Title

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

Details

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.

Keywords

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, Neoplasms, Sarcoma, Lymphoma, Large-Cell, Immunoblastic, Castleman Disease, Recurrence, Biospecimen Collection

Eligibility

For people ages 18 years and up

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.

Locations

  • UCSF accepting new patients
    San Francisco California 94110 United States
  • Huntsman Cancer Institute, University of Utah accepting new patients
    Salt Lake City Utah 84112 United States

Lead Scientist at UCSF

  • Chia-Ching (Jackie) Wang, MD
    Jackie Wang, MD, is an Assistant Professor at University of California, San Francisco and a faculty member in the Division of Hematology-Oncology at Zuckerberg San Francisco General Hospital. Her research interest is in HIV oncology. She is a member of the AIDS Malignancy Consortium. She is certified to perform high-resolution anoscopy to detect anal dysplasia.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AIDS Malignancy Consortium
ID
NCT05663502
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated