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

Sponsor

AIDS Malignancy Consortium (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05663502

Collaborator

National Cancer Institute (NCI) (NIH)

200

Enrollment

149.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Biospecimen Collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Mar 27, 2023

Anticipated Primary Completion Date :

Aug 31, 2030

Anticipated Study Completion Date :

Aug 31, 2035

Arms and Interventions

Arm	Intervention/Treatment
Observational (biospecimen collection) Patients undergo collection of fresh blood and/or tumor tissue samples	Procedure: Biospecimen Collection Undergo blood and/or tumor tissue sample collection Other Names: Biological Sample Collection

Arm

Intervention/Treatment

Observational (biospecimen collection)

Patients undergo collection of fresh blood and/or tumor tissue samples

Procedure: Biospecimen Collection

Undergo blood and/or tumor tissue sample collection

Other Names:

Biological Sample Collection

Outcome Measures

Primary Outcome Measures

Number of biospecimens collected [Through study completion, anticipated to be 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.