NCT05364086

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,100 (estimated)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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: This is an observational study. 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. Patients may also optionally complete an interview following their 2nd infusion of immunotherapy.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of tumor, blood, saliva and stool samples
OTHER	Electronic Health Record Review	Review of medical records
OTHER	Interview	Complete an interview
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2022-04-26
• Primary completion: 2026-10-31
• Completion: 2030-01-31
• First posted: 2022-05-06
• Last updated: 2026-03-13

Locations

259 sites across 1 country: United States