Digestive Biobank for Exploring Microbiota-host Interactions | NCT05704413

Studies
Digestive Biobank for Exploring Microbiota-host Interactions

NCT05704413

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Jan 30, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Colorectal Cancer
Indeterminate Colitis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2021Actual

Primary Completion Date

Sep 17, 2026Estimated

Completion Date

Sep 17, 2026Estimated

First Submitted Date

Feb 18, 2019

First Submission Date that Met QC Criteria

Jan 19, 2023

First Posted Date

Jan 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2023

Last Update Posted Date

Jan 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Conditions Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Jérémie LEFEVRE, PU-PH	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Viscérale - Hôpital Saint Antoine	Recruiting	Paris		75012	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D003424	Crohn Disease
D003093	Colitis, Ulcerative
D015179	Colorectal Neoplasms
D019964	Mood Disorders

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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