NCT05364086|Active Not RecruitingDMC

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

DiRECT

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

University of Rochester NCORP Research Base ClinicalTrials.gov

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5 other identifiers

URCC21038NCI-2022-01426URCC-21038UG1CA189961UH3CA260602

Study Type

observational

Target

2,100

Locations

1 country

Sites

259

Timeline

RegisteredMay 2022

StartedApr 2022

CompletionJan 2030

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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,100

participants targeted

Target at P75+ for all trials

Timeline

46mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach

1 country

259 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.8 years study duration

Study Progress52%

Apr 2022Jan 2030

First Submitted

Initial submission to the registry

March 31, 2022

Completed

26 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected

3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

March 31, 2022

Last Update Submit

March 11, 2026

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

Racial differences in the incidence of Common Terminology Criteria for Adverse Events (CTCAE) grade 2-5 immune-related adverse reactions (irAEs)
Will be evaluated in bivariate analysis by Chi-square, Wilcoxon rank-sum test, or two sample t-tests.
Within 1 year after starting immune checkpoint inhibitor (ICI) treatment

Secondary Outcomes (3)

Racial differences in overall response rate (ORR) between African American (AA) and European American (EA) patients
Within 1 year after starting ICI treatment
Health-related quality of life (HRQOL) - PROPr
Within 1 year after starting ICI treatment
Health-related quality of life (HRQOL) - FACT-ICM
Within 1 year after starting ICI treatment

Study Arms (1)

Observational (questionnaire, biospecimen, medical records))

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.

Procedure: Biospecimen CollectionOther: Electronic Health Record ReviewOther: InterviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration