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NCT04038619 · ClinicalTrials.gov registry record · Phase 1
Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
A Phase 1 study of Breast Cancer and Lung Cancer, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04038619: Recruiting Phase 1 study of Breast Cancer and Lung Cancer, sponsored by M.D. Anderson Cancer Center.
NCT04038619 is a Phase 1 study of Breast Cancer and Lung Cancer that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04038619, a Phase 1 study of Breast Cancer and Lung Cancer, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.
Primary Outcome
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT.
Conditions Studied
Interventions
- PROCEDURE Fecal Microbiota Transplantation
- DRUG Loperamide
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04038619 shows while recruiting
NCT04038619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 9 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fecal Microbiota Transplantation is the first listed.
NCT04038619 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04038619 about?
NCT04038619 is a clinical study titled "Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients". This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effecti...
What is the current status of trial NCT04038619?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-02-01. Estimated completion is 2027-12-31.
What conditions does trial NCT04038619 study?
This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Ovarian Cancer, Melanoma, Cervical Cancer.
What interventions are being tested in trial NCT04038619?
The interventions under investigation include: Fecal Microbiota Transplantation (PROCEDURE), Loperamide (DRUG).
Who is sponsoring clinical trial NCT04038619?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04038619 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
Similar trials for Breast Cancer
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 NCT04038619's enrollment target sits among peer trials
40 876th of 1224 higher than 325 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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