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

NCT05364086 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2100

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Rochester NCORP Research Base

    lead OTHER

Principal Investigators

  • Charles Kamen, PhD · University of Rochester NCORP Research Base

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2026-10-31
Completion
2030-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364086 on ClinicalTrials.gov