An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study
Active: |
Yes
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Cancer Type: |
Hematopoietic Malignancies Solid Tumor
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NCT ID: |
NCT05364086
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Trial Phases: |
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Protocol IDs: |
URCC21038 (primary) URCC-21038 URCC-21038 NCI-2022-01426
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Eligibility: |
18 Years and older, Male and Female
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Study Type: |
Health services research
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Study Sponsor: |
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NCI Full Details: |
http://clinicaltrials.gov/show/NCT05364086
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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. 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.
Objectives
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 American (EA) patients within the first year of starting immune checkpoint inhibitor (ICI) treatment.
SECONDARY OBJECTIVES:
I. To compare objective response rate (ORR) to ICI treatment between AA and EA patients within the first year of starting ICI treatment.
II. To compare health-related quality of life (HRQOL) measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Preference (Patient Reported Outcomes [PRO] Pr) summary score and Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM) between AA and EA patients within 1 year of starting ICI treatment.
EXPLORATORY OBJECTIVES:
I. To compare AA and EA patients on severity (i.e., CTCAE grade) and timing of irAEs within 1 year of starting ICI treatment.
II. To assess disease, treatment, individual, and behavioral factors as predictors of grade 2-5 irAEs, and as potential causes of racial differences in irAEs, within 1 year of starting ICI treatment.
III. To compare AA and EA patients on long-term outcomes (e.g., progression-free survival [PFS], overall survival [OS], and HRQOL beyond the first year) at the end of the study period.
IV. To assess the impact of irAEs and disease, treatment, behavioral, and individual factors on ICI outcomes (ORR, HRQOL, PFS, OS), and as potential causes of racial differences in outcomes, at the end of the study period.
V. To compare ICI treatment patterns (e.g., delay and discontinuation of ICI treatment) between AA and EA patients within 1 year of starting ICI treatment.
VI. To assess irAEs, treatment, disease, and individual factors, including healthcare barriers, as possible reasons for suboptimal treatment patterns, and as potential causes of racial differences, within 1 year of starting ICI treatment.
VII. To collect optional stool samples and an additional blood sample at the time of the occurrence of grade 3-4 irAEs to strengthen the biobank for future research on ICI response and racial disparities.
OUTLINE:
Patients complete questionnaires and undergo collection of blood, saliva, and optional stool samples before 1st and 2nd infusion of immunotherapy. Patients also complete additional questionnaires undergo additional collection of blood samples 6 months after 1st infusion of immunotherapy and then every year after 1st infusion of immunotherapy. A tumor sample will also be collected at the beginning of the study and patients medical records will be reviewed.
Treatment Sites in Georgia
Atlanta Cancer Care - Stockbridge7813 Spivey Station Boulevard
Suite 210
Jonesboro, GA 30236
678 466-2069
www.atlantacancercare.com
Atlanta Gynecologic Oncology980 Johnson Ferry Road
Suite 900
Atlanta, GA 30342
404-303-3355
www.geraldfeuer.com
Georgia Cancer Specialists - Athens125 King Avenue
Suite 200
Athens, GA 30606
www.gacancer.com
Georgia Cancer Specialists - Canton228 Riverstone Drive
Canton, GA 30114
www.gacancer.com
Georgia Cancer Specialists - CenterPointe1100 Johnson Ferry Road
Suite 600
Sandy Springs, GA 30342
404-256-4777 ext 9242
www.gacancer.com
Georgia Cancer Specialists - Decatur2712 Lawrenceville Highway
Decatur, GA 30033
404-303-3355
www.gacancer.com
Georgia Cancer Specialists - Kennestone790 Church Street
Suite 335
Marietta, GA 30060
www.gacancer.com
Georgia Cancer Specialists - Macon-Coliseum308 Coliseum Drive
Suite 120
Macon, GA 31217
478-745-6130 x8152
www.gacancer.com
Georgia Gynecologic Oncology980 Johnson Ferry Road
Suite 910
Atlanta, GA 30342
404-303-3355
www.ggo-atl.com/
John B Amos Cancer Center
1831 Fifth Avenue
Columbus, GA 31904
706-780-6201
Nancy N. and J.C. Lewis Cancer Research Pavilion at St. Joseph Candler225 Candler Drive
Savannah, GA 31405
912-819-5778
www.sjchs.org
Northside Hospital Cancer Institute1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com
Pearlman Cancer Center at South Georgia Medical Center2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org
University Gynecologic Oncology960 Johnson Ferry Road
Suite 130
Atlanta, GA 30342
404-303-3355
www.ugynonc.com
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