Status:
RECRUITING
An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study
Lead Sponsor:
University of Rochester NCORP Research Base
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Brief Summary
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. Col...
Detailed Description
PRIMARY OBJECTIVE: I. To compare incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs) between African American (AA) and European Amer...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2030
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT05364086
Start Date
April 26 2022
End Date
January 31 2030
Last Update
May 2 2025
Active Locations (259)
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1
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States, 72401
2
Kaiser Permanente-Anaheim
Anaheim, California, United States, 92806
3
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
4
Kaiser Permanente-Baldwin Park
Baldwin Park, California, United States, 91706