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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05037825
The ClinicalTrials.gov registry entry for NCT05037825 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 236-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (239% higher). The listed sponsor is VastBiome, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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