Active, currently enrolling
Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting
NCT No.: NCT05364086
Study Type: INTERVENTIONAL
Phase:
n/a
Region: California - Northern
Acronym:
Official Title
Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting
Purpose
This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood, saliva, stool, and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand healthcare disparities among all cancer patients.
Detailed Description
Eligibility Criteria
Inclusion Criteria
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• Be 18 years of age or older
• Self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA)
• Patients may identify a Hispanic/Latino ethnicity in combination
with an AA or EA racial identity
• Have a current diagnosis of invasive cancer at stage I-IV
• Patients may have a history of previous cancer diagnosis and
cancer treatment not involving immunotherapy
• Be scheduled to receive anti-PD-1/-L1 ICI-containing therapy alone or in combination with co-treatments (including alternative ICIs)
• Be able to speak and read English or Spanish
• Be able to provide informed consent
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Exclusion Criteria
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• Identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• Be diagnosed with melanoma (because melanoma is very rare in AAs)
• Currently participate in any trials of a cancer therapeutic nature; participation in noninterventional trial, or trials of symptom control or supportive nature is allowed; participation in future cancer therapeutic trials after completing the A2 assessment (e.g., after the second infusion of ICIs) is also allowed
• Have received prior immunotherapy for cancer, including checkpoint inhibitors, chimeric antigen receptor (CAR)-T therapy, cytokine therapy, and/or Bacillus Calmette-Guerin (BCG) for bladder cancer
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Keywords and/or Specific Medical Conditions
Sponsors
- University of Rochester NCORP Research Base
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