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NCT03819296 · ClinicalTrials.gov registry record · Phase 1
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
A Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 800
- Enrollment target
- 1
- Study location
NCT03819296: Recruiting Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03819296 is a Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 800 participants, above the 127-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (530% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03819296, a Phase 1 study of Clinical Stage IV Cutaneous Melanoma AJCC v8 and Clinical Stage III Cutaneous Melanoma AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 800 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
Primary Outcome
The primary endpoint is alpha diversity of bacteria species (measured using inverse Simpson index). It is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases.
Conditions Studied
Interventions
- BIOLOGICAL Infliximab
- OTHER Best Practice
- PROCEDURE Fecal Microbiota Transplantation
- OTHER Biospecimen Collection
- PROCEDURE Endoscopic Procedure
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2021-02-21 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 1 |
What NCT03819296 shows while recruiting
NCT03819296 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 127-participant average among 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials with a reported enrollment target (530% higher).
The record links to 10 conditions, with Clinical Stage IV Cutaneous Melanoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Infliximab is the first listed.
NCT03819296 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03819296 about?
NCT03819296 is a clinical study titled "Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer". This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whe...
What is the current status of trial NCT03819296?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 800 participants. The study started on 2021-02-21. Estimated completion is 2026-10-31.
What conditions does trial NCT03819296 study?
This clinical trial studies the following conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8, Clinical Stage IB Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT03819296?
The interventions under investigation include: Infliximab (BIOLOGICAL), Best Practice (OTHER), Fecal Microbiota Transplantation (PROCEDURE), Biospecimen Collection (OTHER), Endoscopic Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT03819296?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03819296 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03819296's enrollment target sits among peer trials
800 2nd of 32 the highest of 32 other Clinical Stage IV Cutaneous Melanoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage IV Cutaneous Melanoma AJCC v8 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.
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