NCT02392221

Brief Summary

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
966

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

March 12, 2015

Last Update Submit

April 22, 2026

Conditions

Keywords

Crohn's disease (CD)PediatricInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of surgical resection in CD and colectomy in pediatric UC

    Cumulative incidence of surgical resection in CD and colectomy in pediatric ulcerative colitis, depending on the date of diagnosis and the possibility of using immunosuppressants and / or anti-TNFs.

    end of follow up

Secondary Outcomes (15)

  • Disease extension according to Montreal classification

    end of follow up

  • Treatment during the follow up

    end of follow up

  • information about occurrence of postoperative complications

    end of follow up

  • Weight and size

    end of follow up

  • Hospitalisations

    end of follow up

  • +10 more secondary outcomes

Eligibility Criteria

AgeUp to 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric IBD patients in the area of EPIMAD registry Age of diagnosis \< 17 years

You may qualify if:

  • Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2011.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU Lille

Lille, Lille, 59000, France

Location

CHU Rouen

Rouen, Rouen, 7700, France

Location

Related Publications (1)

  • Ley D, Leroyer A, Dupont C, Sarter H, Bertrand V, Spyckerelle C, Guillon N, Wils P, Savoye G, Turck D, Gower-Rousseau C, Fumery M; Epimad Group. New Therapeutic Strategies Have Changed the Natural History of Pediatric Crohn's Disease: A Two-Decade Population-Based Study. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2588-2597.e1. doi: 10.1016/j.cgh.2022.01.051. Epub 2022 Feb 4.

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Mathurin Fumery, Doctor

    CHU Amiens France

    STUDY DIRECTOR
  • Jean-Louis Dupas, professor

    CHU Amiens France

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations