Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC
NCT ID: NCT05510908
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
462 participants
OBSERVATIONAL
2023-07-25
2025-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New, primary or recurrent disease
Considering or currently receiving cancer treatment
Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Metastic or locally advanced cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Prior cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Interventions
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Non-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
Non-Interventional Follow-up
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Eligibility Criteria
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Inclusion Criteria
* 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 health care provider;
* Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the 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;
* HIV-1 RNA detection by a licensed HIV-1 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-1 Western blot confirmation 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 cancer treatment
* Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies.
* Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy.
* Age ≥ 18 years.
* Participant presents to an AMC domestic clinical trial site for either clinical care or research.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Locations
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Moores UCSD Cancer Center
La Jolla, California, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Weill Cornell Medicine - Cornell Clinical Trials Unit
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Ohio State University
Columbus, Ohio, United States
Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute - University of Utah
Salt Lake City, Utah, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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Other Identifiers
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AMC-115
Identifier Type: -
Identifier Source: org_study_id
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