The Gut Microbiome and Immunotherapy Response in Solid Cancers

Part of paid clinical trials in Galveston, Texas.

Sponsor
The University of Texas Medical Branch, Galveston
Study ID
NCT06050733
Status
Recruiting
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Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Study Details

The aim of this study is characterize the gastrointestinal microbiomes of patient with solid cancer undergoing standard of care treatment with programmed cell death protein 1 (PD-1) /programmed cell death ligand (PD-L1) blockade.

Key Dates

Start date
Jun 30, 2023
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
16 participants (estimated)

Arms

  • Arm: Solid cancer patients with disease progression
    8 patients with a diagnosis of solid cancer undergoing standard of care treatment, with a PD-1 or PD-L1 inhibitor, with disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
  • Arm: Solid cancer patients with stable or experience shrinkage in tumor size
    8 patients with a diagnosis of solid cancer undergoing standard of care treatment, with a PD-1 or PD-L1 inhibitor, with tumor size stable or shrinkage, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

Primary Outcome Measure

Characterization of fecal microbiome using molecular methods [ Time Frame: baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical BranchGalvestonTexas77845
Kristen McGovern, PhD
[email protected]
409-772-8126
Kate Randolph, BS
[email protected]
409-223-7891

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