Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362174
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-13
Brief Title:
Capsule Omics for pRedicting Exacerbation of Crohns Disease
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Capsule Omics for pRedicting Exacerbation of Crohns Disease CORE-CD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
CORE-CD
Brief Summary:
The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohns disease in remission demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers Subsequently deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images The investigators will advance this knowledge using a parallel two-parts approach
Detailed Description:
Part I - A retrospective study will use stored capsule and clinical datasets from 120 previously enrolled CD patients in remission who underwent capsule based 24-months monitoring as part of two prior similar research projects 60 in each of the Israeli Inflammatory bowel disease Research Nucleus IIRN IIRN-I and IIRN-II-CURE- projects aiming to predict and prevent flares based on capsule studies The investigators will now utilize the accumulated visual data to develop AI-based complete film readouts and integrate the resultant visual omics data with previously derived microbiome and biomarker data to serve as a discovery cohort for machine learning models predicting clinical exacerbation in patients in remission which was witnessed in 27 of IIRN-I cohort within the 24m study
Part II - A prospective observational study will enroll a new IIRN-III cohort of 60 6 attrition-considered Crohns Disease patients16 years old in clinical remission The investigators will deliberately use similar inclusion monitoring design and outcome definitions as IIRN-I II studies to allow cross-cohort comparative validity Procedures will include baseline colonoscopy pan-enteric capsule and magnetic resonance enterographyIntestinal ultrasound and thereafter serial capsule studies or every 6 months for 24 months Newly acquired Omics will include baseline mucosal colonic wash transcriptomics obtained during the baseline colonoscopy serial dense stool microbiome and blood metabolomics and a computerized frequency questionnaire diet omics data A densely sampled 24 months stool will be used to develop novel multi-omics tools predicting flares The investigators will also use the datasets to explore the mechanisms and pathways involved in triggering remission transition into a clinical flare
Follow- up can optionally extend to 36 months
Part II - A prospective observational study will enroll a new IIRN-III cohort of 60 6 attrition-considered Crohns Disease patients16 years old in clinical remission The investigators will deliberately use similar inclusion monitoring design and outcome definitions as IIRN-I II studies to allow cross-cohort comparative validity Procedures will include baseline colonoscopy pan-enteric capsule and magnetic resonance enterographyIntestinal ultrasound and thereafter serial capsule studies or every 6 months for 24 months Newly acquired Omics will include baseline mucosal colonic wash transcriptomics obtained during the baseline colonoscopy serial dense stool microbiome and blood metabolomics and a computerized frequency questionnaire diet omics data A densely sampled 24 months stool will be used to develop novel multi-omics tools predicting flares The investigators will also use the datasets to explore the mechanisms and pathways involved in triggering remission transition into a clinical flare
Follow- up can optionally extend to 36 months
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