Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760964
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2021-02-17
Brief Title:
Mitochondrial DAMPs as Mechanistic Biomarkers of Mucosal Inflammation in Crohns Disease and Ulcerative Colitis
Sponsor:
Organization:
University of Edinburgh
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
SALIVA 1 sample for DNA sampling BLOOD At each time point 40mls of blood will be taken Serum for normal IBD care and MediatorsBiomarkers Serum proteins and LC-MS EDTA tubes for normal IBD care and Mediatorsmetabolitesbiomarkers RNA tube PAXgene for RNA sequencing of host transcriptome ILEO-COLONOSCOPY SAMPLES Standard research sampling involves 4 biopsies 2 for formalin fixation and 2 for RNA-later from ileum the small bowel caecum transverse colon and rectum respectively Total of 16 biopsies
STOOL SAMPLES For Microbiome Next Generation SequencingCalprotectinStool biomarkers and faecal immunochemical test FIT
In selected patients
BLOOD SAMPLES 10-20 participants with anticipated high DAMP release 10-20 IBD patients with inactive quiescent disease
SURGICAL SAMPLES Surplus tissue may be obtained from specimens of the colon and ileum that have been surgically removed either at the time of operation or during histopathological evaluation
Enrollment Count:
250
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Case-Only |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 72987 |
Who Masked List: