An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study

Description

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 and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

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Study Overview

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Study Details

Study overview

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 and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.

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

An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study

Condition
Hematopoietic and Lymphoid Cell Neoplasm
Intervention / Treatment

-

Contacts and Locations

Jonesboro

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro, Jonesboro, Arkansas, United States, 72401

Anaheim

Kaiser Permanente-Anaheim, Anaheim, California, United States, 92806

Antioch

Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States, 94531

Baldwin Park

Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States, 91706

Bellflower

Kaiser Permanente-Bellflower, Bellflower, California, United States, 90706

Dublin

Kaiser Permanente Dublin, Dublin, California, United States, 94568

Fontana

Kaiser Permanente-Fontana, Fontana, California, United States, 92335

Fremont

Kaiser Permanente-Fremont, Fremont, California, United States, 94538

Fresno

Kaiser Permanente-Fresno, Fresno, California, United States, 93720

Harbor City

Kaiser Permanente South Bay, Harbor City, California, United States, 90710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester NCORP Research Base,

Charles Kamen, PhD, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

Study Record Dates

2030-01-31