Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06349590
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-14
Brief Title:
Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
A Phase 12 Study of Manipulation of the Gut Microbiome by a Standardized Preoperative Diet to Prevent Colorectal Cancer Recurrence and Metastasis Following Surgery The DIET Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIET
Brief Summary:
A single arm prospective single center Phase12 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-fiberlow-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 andor during the follow-up period
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None