Trial Title:
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
NCT ID:
NCT05663502
Condition:
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
Conditions: Official terms:
Sarcoma, Kaposi
Lymphoma
Neoplasms
Sarcoma
Plasmablastic Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Castleman Disease
Recurrence
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and/or tumor tissue sample collection
Arm group label:
Observational (biospecimen collection)
Other name:
Biological Sample Collection
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.
Criteria for eligibility:
Study pop:
Study population includes patients with human immunodeficiency virus (HIV) infection and
HIV-associated malignancies, as well as HIV-negative cancer patients.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ivan Leung
Phone:
628-206-7748
Email:
ivan.leung@ucsf.edu
Investigator:
Last name:
Chia-Ching (Jackie) Wang, MD
Email:
Principal Investigator
Facility:
Name:
George Washington University
Address:
City:
Washington
Zip:
20052
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lakeisha McCormick
Phone:
202-994-0872
Email:
lmccorm@gwu.edu
Investigator:
Last name:
Sharad Goyal, MD
Email:
Principal Investigator
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21774
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura Clark
Phone:
410-502-5396
Email:
lclark53@jhmi.edu
Investigator:
Last name:
Richard Ambinder, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ariela Noy, MD
Phone:
646-608-3727
Email:
noya@mskcc.org
Investigator:
Last name:
Ariela Noy, MD
Email:
Principal Investigator
Facility:
Name:
Huntsman Cancer Institute, University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gayatri Nachaegari
Phone:
801-213-4329
Email:
gayatri.nachaegari@hci.utah.edu
Investigator:
Last name:
Gita Suneja, MD, MSHP
Email:
Principal Investigator
Start date:
May 10, 2023
Completion date:
August 31, 2035
Lead sponsor:
Agency:
AIDS Malignancy Consortium
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
AIDS Malignancy Consortium
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05663502
