Digestive Biobank for Exploring Microbiota-host Interactions

Colorectal Cancer Clinical Trial

— BiomHost  

Official title:

Digestive Biobank for Exploring Microbiota-host Interactions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704413
• Other study ID #: APHP180540
• Status: Recruiting
• Start date: June 17, 2021
• Est. completion date: September 17, 2026

Study information

• Verified date: January 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jérémie LEFEVRE, PU-PH
• Phone: +33 (0)1 49 28 25 63
• Email: jeremie.lefevre[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 17, 2026
• Est. primary completion date: September 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ulcerative colitis, Crohn's disease or colorectal disease

• Digestive resection with useless tissue available

• Information consent signed

Exclusion Criteria:

• Patients < 18 years

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Colorectal Cancer
• Colorectal Neoplasms
• Crohn Disease
• Indeterminate Colitis
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
France	Service de Chirurgie Viscérale - Hôpital Saint Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation between biological parameters and outcomes of digestive disease (IBD, CRC)	identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.	up to 12 months after the incusion
Secondary	Relation between biological parameters and outcomes of digestive disease (IBD, CRC)	identify relations between plasma on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.	up to 12 months after the incusion
Secondary	Relation between biological parameters and outcomes of digestive disease (IBD, CRC)	identify relations between DNA on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.	up to 12 months after the incusion
Secondary	Relation between biological parameters and outcomes of digestive disease (IBD, CRC)	identify relations between faeces) on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.	up to 12 months after the incusion
Secondary	Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications	genetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications	up to two months after the incusion
Secondary	Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments	genetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments	up to two months after the incusion
Secondary	Exploratory study on the physiopathology of host-microbiota interactions	genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota	up to two months after the incusion
Secondary	Brain-microbiota interaction	Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways	up to two months after the incusion