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NCT06349590 · ClinicalTrials.gov registry record · Phase 1
Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery
A Phase 1 study of Colorectal Cancer, sponsored by University of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06349590: Recruiting Phase 1 study of Colorectal Cancer, sponsored by University of Chicago.
NCT06349590 is a Phase 1 study of Colorectal Cancer that is actively recruiting participants, run by University of Chicago. The registered enrollment target is 80 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06349590, a Phase 1 study of Colorectal Cancer, is actively recruiting participants, sponsored by University of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary up until lunch on the day prior to surgery. Blood samples will be collected at baseline and on the day of surgery. Stool samples will be collected throughout the dietary intervention period at specific timepoints, on the day of surgery, and 30 days post-surgery. Tissue from the tumor resection will be isolated for organoid cultures. Subjects will be followed per standard of care for up to 5 years or disease recurrence, whichever comes first. Subject may be treated for their cancer prior to surgery and/or during the follow-up period.
Primary Outcome
To assess whether the dietary intervention significantly changed the collagenase activity, the site will compare each subject's baseline and final values.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT High-fiber/low-fat meals
Study Locations (1)
Illinois
- University of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2029-10 |
| Phase | Phase 1 |
What NCT06349590 shows while recruiting
NCT06349590 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which High-fiber/low-fat meals is the first listed.
NCT06349590 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06349590 about?
NCT06349590 is a clinical study titled "Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery". A single arm, prospective, single center Phase1/2 Dietary intervention trial for subjects diagnosed with colorectal cancer and scheduled for tumor resection more than 21 days from informed consent. Subjects will be provided 21 days of standardized High-fiber/low-fat meals and complete a food diary u...
What is the current status of trial NCT06349590?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2024-06-27. Estimated completion is 2029-10.
What conditions does trial NCT06349590 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT06349590?
The interventions under investigation include: High-fiber/low-fat meals (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06349590?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06349590 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal 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 NCT06349590's enrollment target sits among peer trials
80 230th of 381 higher than 148 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal 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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