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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 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 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06349590
The ClinicalTrials.gov registry entry for NCT06349590 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (95% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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