Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC

Last updated: April 9, 2025
Sponsor: AIDS Malignancy Consortium
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sarcoma

Rectal Cancer

Anal Dysplasia

Treatment

Non-Interventional Follow-up

Non-Interventional

Clinical Study ID

NCT05510908
AMC-115
UM1CA121947
  • Ages > 18
  • All Genders

Study Summary

This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant can understand and is willing to sign a written informed consentdocument.

  • HIV positive. Documentation of HIV-1 infection by means of any one of the following:

  • Documentation of an HIV diagnosis in the medical record by a licensed healthcare provider;

  • Documentation of receipt of antiretroviral therapy (ART) (i.e., at least twodifferent medications that do not constitute a prescription for pre-exposureprophylaxis [PrEP]) by a licensed health care provider. Documentation may be arecord of an ART prescription in the medical record, a written prescription inthe name of the participant for ART, or pill bottles for ART with a labelshowing the participant's name;

  • HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNAcopies/mL;

  • Any licensed HIV screening antibody and/or HIV antibody/antigen combinationassay confirmed by a second licensed HIV assay such as a HIV-1 Western blotconfirmation or HIV rapid multispot antibody differentiation assay.

Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).

WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay, or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load.

  • Patient was diagnosed with or treated for cancer within the last 5 years.Participants will qualify under one of three categories:

  • New, primary or recurrent diagnosis -Considering or currently receiving cancertreatment

  • Metastatic or locally advanced cancer - This includes cases for which there areno current definitive therapy options for cure (i.e., inoperable) but may beconsidered for non-standard / non-curative therapies.

  • Prior diagnosis (within 5 years), in remission - Not currently on cancertreatment other than ART or maintenance therapy.

  • Age ≥ 18 years.

  • Participant presents to an AMC domestic clinical trial site for either clinical careor research.

Exclusion

Exclusion Criteria:

  • Participants who do not fulfill the criteria as listed above are ineligible.

Study Design

Total Participants: 720
Treatment Group(s): 2
Primary Treatment: Non-Interventional Follow-up
Phase:
Study Start date:
July 25, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • University of Puerto Rico

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Moores UCSD Cancer Center

    La Jolla, California 92903
    United States

    Site Not Available

  • George Washington University Cancer Center

    District of columbia, District of Columbia 20037
    United States

    Site Not Available

  • George Washington University Cancer Center

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Weill Cornell Medicine - Cornell Clinical Trials Unit

    New York, New York 10010
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania 19106
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Huntsman Cancer Institute - University of Utah

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

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