NCT02874365

Brief Summary

A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

November 28, 2025

Status Verified

December 1, 2024

Enrollment Period

6.3 years

First QC Date

May 13, 2016

Last Update Submit

November 21, 2025

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • number of organoids

    number of organoids in culture wells during the follow-up

    2 days

Secondary Outcomes (2)

  • mean size of organoids

    2 days

  • percentage of different types of organoids

    2 days

Study Arms (4)

Crohn disorder

EXPERIMENTAL

arm composed by 30 patients with Crohn disorder

Procedure: Endoscopic biopsies

FAP (familial adenomatous polyposis )

EXPERIMENTAL

arm composed by 30 patients with FAP disorder

Procedure: Endoscopic biopsies

ulcerative colitis

EXPERIMENTAL

arm composed by 30 patients with ulcerative colitis

Procedure: Endoscopic biopsies

witness

SHAM COMPARATOR

arm composed by 30 patients with no intestinal disorders

Procedure: Endoscopic biopsies

Interventions

Endoscopic biopsiesPROCEDURE

intestinal biopsies

Crohn disorderFAP (familial adenomatous polyposis )ulcerative colitiswitness

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital des Enfants

Toulouse, 31159, France

Location

Related Publications (2)

  • Laborde N, Barusseaud A, Quaranta M, Rolland C, Arrouy A, Bonnet D, Kirzin S, Sola-Tapias N, Hamel D, Barange K, Duffas JP, Gratacap MP, Guillermet-Guibert J, Breton A, Vergnolle N, Alric L, Ferrand A, Barreau F, Racaud-Sultan C, Mas E. Human colonic organoids for understanding early events of familial adenomatous polyposis pathogenesis. J Pathol. 2025 Jan;265(1):26-40. doi: 10.1002/path.6366. Epub 2024 Dec 6.

    PMID: 39641466BACKGROUND

  • Moreau J, Mas E. Drug resistance in inflammatory bowel diseases. Curr Opin Pharmacol. 2015 Dec;25:56-61. doi: 10.1016/j.coph.2015.11.003. Epub 2015 Nov 29.

    PMID: 26645664BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Emmanuel MAS, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

August 22, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 27, 2023

Last Updated

November 28, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)