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The Effect of the Microbiome on Immune Checkpoint Inhibitor Response in Melanoma Patients

NCT05102773 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2023-04-24

No results posted yet for this study

Summary

This pilot trial studies the effect of the microbiome on immune checkpoint inhibitors response in patients with melanoma by collecting stool and blood samples. Gut microbiome plays a critical role in response to immune checkpoint inhibitors. Studying the change in an individual's microbiome due to corticosteroid use may help researchers to determine whether an individual's microbiome can predict their response and toxicity to immune checkpoint inhibitors.

Conditions

  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood and stool

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Questionnaire Administration

Complete questionnaire

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Daniel Spakowicz, PhD · Ohio State University Comprehensive Cancer Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2022-05-05
Completion
2022-05-05

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 NCT05102773 on ClinicalTrials.gov