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NCT06630429

A Pilot Study of Blood-based Biomarkers for Response to Immune Checkpoint Inhibitors

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

A pilot study evaluating baseline and on-treatment changes in tumor fraction (TFx) in peripheral blood in patients with NSCLC and RCC being treated with checkpoint inhibitor therapy as part of standard of care. The primary objective of the study is to determine whether baseline TFx can be reliably predicted in patients with NSCLC and RCC and if changes can be detected during treatment that may correlate with response. Exploratory analyses will be completed to assess the potential roles of cachexia-associated inflammation, tumor-associated increases in glucocorticoid secretion, and ketosis/ketogenesis in both elevated mAb clearance and in response to ICI therapy. Measurements will include circulating IL-6 and other cytokine levels, glucocorticoid levels, ketone levels and stool analysis for assessment of gut microbiome.

Official title: A Pilot Study of Blood-Based Biomarkers for Response to Immune Checkpoint Inhibitors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2020-09-02

Completion Date

2026-07-31

Last Updated

2025-11-10

Healthy Volunteers

Not specified

Interventions

OTHER

Biospecimen Collection

Undergo collection of blood and stool samples

Locations (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States