NCT03809728

Brief Summary

Interventional study of a group of patients with an inflammatory bowel disease (IBD; Crohn's disease (CD) or ulcerative colitis (UC)) to identify predictive and prognostic biomarkers of natural history and response to biotherapies.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
104mo left

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress43%
Dec 2019Dec 2034

First Submitted

Initial submission to the registry

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2034

Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

15 years

First QC Date

January 17, 2019

Last Update Submit

February 6, 2024

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who have lost response to biotherapies (anti-TNF, ustekinumab, vedolizumab).

    5 years

Secondary Outcomes (6)

  • Proportion of patients who underwent surgery

    5 years

  • Post-operative morbidity rates in IBD

    5 years

  • Surgical recurrent rate in Crohn's disease

    5 years

  • Proportion of patients with a destruction of the intestinal wall in CD (abscess, fistula)

    5 years

  • Proportion of patients developing a cancer

    5 years

  • +1 more secondary outcomes

Study Arms (1)

IBD patients

OTHER

All patients with an established Crohn's disease or ulcerative colitis

Procedure: endoscopic biopsyProcedure: samples of the oral cavityProcedure: Samples of the resected specimen

Interventions

endoscopic biopsyPROCEDURE

Per-endoscopic biopsies

IBD patients
samples of the oral cavityPROCEDURE

7 samples of the oral cavity with a swab

IBD patients
Samples of the resected specimenPROCEDURE

if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised

IBD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>=18 years
  • Patients with an established diagnosis of CD or UC (clinical, biological, radiological, endoscopic or histologic criteria)
  • Patients \>=45 kg
  • Affiliated member of the Social Security system

You may not qualify if:

  • Patients with an undetermined colitis
  • Patients with a non established diagnosis of CD
  • Women of childbearing age without a method of contraception
  • Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
  • Pregnant women, breastfeeding women
  • \-- Age \< 18 years
  • Persons under legal protection
  • Person who does not have the capacity to consent
  • Persons under the age of 18 years who are deprived of their liberty by decision of a judicial or administrative authority (articles L. 3212-1 and L. 3213-1).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54510, France

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic 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

  • Adeline GERMAIN, MD, PhD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeline GERMAIN, MD, PhD

CONTACT

+33383153120a.germain@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

December 10, 2019

Primary Completion (Estimated)

December 10, 2034

Study Completion (Estimated)

December 10, 2034

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

FR(1)