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Trial Title:
Digestive Biobank for Exploring Microbiota-host Interactions
NCT ID:
NCT05704413
Condition:
Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Colorectal Cancer
Indeterminate Colitis
Conditions: Official terms:
Colorectal Neoplasms
Colitis
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Conditions: Keywords:
Microbiota
inflammatory bowel disease
Crohn's disease
ulcerative colitis
colorectal cancer
post-operative cognitive disorders
mood disorders
immune system.
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Constitution of a biobank of tissues, whole blood and plasma samples and stools to
identify markers associated with treatment response, postoperative morbidity including
neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or
colorectal cancer.
Detailed description:
Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent
affections and the microbiota plays a major role in their physiopathology involving the
immune system. In this setting, the interplay between gut microbiota and brain is still
unexplored.
To evaluate the interaction of the microbiota and the immune system with the host in
these two chronic diseases, we aim to create a prospective biobank.
A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll
samples will also be taken from the patient.
All samples will be anonymized.
Criteria for eligibility:
Study pop:
Patients older than 18 years-old. With an Ulcerative colitis, Crohn's Disease or
colorectal cancer Operated in the Departement of digestive surgery of Saint-Antoine
Hospital After signature of the information consent
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Ulcerative colitis, Crohn's disease or colorectal disease
- Digestive resection with useless tissue available
- Information consent signed
Exclusion Criteria:
- Patients < 18 years
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Service de Chirurgie Viscérale - Hôpital Saint Antoine
Address:
City:
Paris
Zip:
75012
Country:
France
Status:
Recruiting
Contact:
Last name:
Jérémie LEFEVRE, PU-PH
Phone:
+33 (0)1 49 28 25 63
Email:
jeremie.lefevre@aphp.fr
Contact backup:
Last name:
Harry SOKOL, PU-PH
Phone:
+33 (0)1 49 28 25 63
Email:
harry.sokol@aphp.fr
Investigator:
Last name:
Franck VERDONK, MD, PhD
Email:
Sub-Investigator
Start date:
June 17, 2021
Completion date:
September 17, 2026
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704413
