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NCT05037825 · ClinicalTrials.gov registry record
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
A clinical trial of Renal Cell Carcinoma and Triple Negative Breast Cancer, sponsored by VastBiome.
- Recruiting
- Registry status
- 800
- Enrollment target
- 1
- Study location
NCT05037825: Recruiting study of Renal Cell Carcinoma and Triple Negative Breast Cancer, sponsored by VastBiome.
NCT05037825 is a study of Renal Cell Carcinoma and Triple Negative Breast Cancer that is actively recruiting participants, run by VastBiome. The registered enrollment target is 800 participants, above the 236-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (239% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05037825, a study of Renal Cell Carcinoma and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by VastBiome.
- RECRUITING
- Registry status
- 800 participants
- Enrollment target
- 1
- Study location
Study Summary
The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.
Primary Outcome
Microbiome evaluation with whole metagenome shotgun sequencing to assess changes in the relative abundance of microbial taxa (measured as percentage abundance per microbial species and changes in percentage abundance between baseline and cycle 2 timepoints) in patients who are receiving checkpoint blockade immunotherapy as the standard of care
Conditions Studied
Interventions
- DRUG Checkpoint Inhibitor, Immune
Study Locations (1)
Kentucky
- Baptist Health Clinical Research - Elizabethtown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2021-11-22 |
| Est. Completion | 2028-09-14 |
What NCT05037825 shows while recruiting
NCT05037825 is an observational study that tracks outcomes without assigning an intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 236-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (239% higher).
The record links to 4 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Checkpoint Inhibitor, Immune is the first listed.
NCT05037825 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT05037825 about?
NCT05037825 is a clinical study titled "The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors". The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. Howeve...
What is the current status of trial NCT05037825?
This trial is currently recruiting. The enrollment target is 800 participants. The study started on 2021-11-22. Estimated completion is 2028-09-14.
What conditions does trial NCT05037825 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma, Triple Negative Breast Cancer, Non-Small-Cell Lung Carcinoma, Malignant Melanoma.
What interventions are being tested in trial NCT05037825?
The interventions under investigation include: Checkpoint Inhibitor, Immune (DRUG).
Who is sponsoring clinical trial NCT05037825?
This trial is sponsored by VastBiome, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05037825 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Renal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05037825's enrollment target sits among peer trials
800 8th of 121 higher than 114 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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