Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial of the Utility of Random Biopsies in Patients With Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
URBI
Brief Summary:
The proposed study is a multicenter parallel group clinical trial that will include 821 evaluable patients per group who will be randomly assigned to either high definition white light colonoscopy HDWLC with targeted biopsies plus 2 random biopsies in 4 segments to assess for inflammation limited biopsy strategy or HDWLC with targeted biopsies plus 4 biopsies every 10 cm throughout the colon at a minimum in all segments of the colon known to have been affected by IBD at any time regardless of the extent of disease random biopsy strategy Participants will be followed until total proctocolectomy or the end of the study period to determine whether the two methods of surveillance colonoscopy are associated with detection of dysplasia or sessile serrated adenoma at follow-up colonoscopy Follow-up via chart review may continue for up to 15 years from enrollment
Detailed Description:
To maximize the yield of surveillance colonoscopy minimize risk to patients and deliver cost-effective care it is imperative to resolve whether random biopsies are warranted for patients with long standing Inflammatory Bowel Disease IBD undergoing dysplasia and colorectal cancer CRC surveillance with high-definition white light colonoscopy HDWLC For this protocol dysplasia surveillance refers to the process of identifying precancerous dysplasia sessile serrated adenoma SSA or CRC This protocol describes a pragmatic multicenter randomized trial of patients with IBD undergoing dysplasia surveillance with HDWLC the most common type of surveillance colonoscopy performed in the US to definitively answer this question
The primary objective of the study is to determine if HDWLC using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect dysplasia or sessile serrated adenoma SSA in patients with IBD
Secondary objectives include
1 Determine if HDWLC using a limited biopsy strategy is superior to HDWLC with a random biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD
2 Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained
The primary objective of the study is to determine if HDWLC using a limited biopsy strategy is non-inferior to HDWLC using a random biopsy strategy to detect dysplasia or sessile serrated adenoma SSA in patients with IBD
Secondary objectives include
1 Determine if HDWLC using a limited biopsy strategy is superior to HDWLC with a random biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD
2 Determine whether the number of targeted biopsies differs based on the number of random biopsies obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None