Digestive Biobank for Exploring Microbiota-host Interactions

NCT05704413 | Recruiting

• 1 other identifier: APHP180540
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Colorectal Cancer; Indeterminate Colitis

Keywords

Microbiota; inflammatory bowel disease; Crohn's disease; ulcerative colitis; colorectal cancer; post-operative cognitive disorders; mood disorders; immune system.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

  up to 12 months after the incusion

• Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

  up to 12 months after the incusion

• Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

  up to 12 months after the incusion

• Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications

  up to two months after the incusion

• Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments

  up to two months after the incusion

Study Arms (1)

digestive cancer or IBD

Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Ulcerative colitis, Crohn's disease or colorectal disease
• Digestive resection with useless tissue available
• Information consent signed

You may not qualify if:

• \- Patients \< 18 years

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Chirurgie Viscérale - Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Intestinal surgical waste: Surgical samples will be rinsed in saline and aliquoted in dry tubes (minimum 5 aliquots) and lateral RNA (minimum 3 aliquots) and then frozen at -80°C * Intestinal contents: They will be aliquoted (at least 5 aliquots) in dry tubes for freezing at -80°C * blood samples (1 dry tube and 2 EDTA tubes of 7ml): centrifigation and aliquoting of serum and plasma, storage at -80°C * whole blood samples (1 sodium heparin tube of 5ml) : stimulation and fixation with proteomic stabilizer, storage at -80° * DNA ; Stored at -20°C * stools: aliquoting and storage at -80°C

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Colorectal Neoplasms; Mood Disorders

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases; Mental Disorders

Study Officials

• Jérémie LEFEVRE, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jérémie LEFEVRE, PU-PH

CONTACT

+33 (0)1 49 28 25 63; jeremie.lefevre@aphp.fr

Harry SOKOL, PU-PH

CONTACT

+33 (0)1 49 28 31 71; harry.sokol@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: January 30, 2023
• Study Start: June 17, 2021
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

FR (1)