Clinical Trial 22531

• Overview

  Study Title:

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

  Objective:

  Primary Objective - To estimate the number of cancers in PWH who present for care at domestic AMC sites Secondary Objectives - To characterize participants that are eligible but not enrolled onto AMC trials to understand site-specific and trial-specific accrual barriers, particularly for minority and underserved populations. Exploratory Objectives - To standardize and expand the quantity and quality of sociodemographic (e.g., racial/ethnic distribution, SES), HIV-related [e.g., Antiretroviral Therapy (ART) medications, co-morbidities], and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. -To describe cancer patient health-related Quality of Life (QOL) for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] and Supportive Care Needs Survey Short Form 34 [SCNS-SF34].

• Inclusion Criteria

  Inclusion Criteria:
  • Participant can understand and is willing to sign a written informed consent document
  • 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.
  • 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 greater than 18 years.
  • Participant presents to an Aids Malignancy Consortium (AMC) domestic clinical trial site for either clinical care or research.

• Exclusion Criteria

  Exclusion Criteria:
  • Participants who do not fulfill the Inclusion Criteria are not eligible.

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