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OpenTrials
Completed

NCT Number: NCT02549976

Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis

The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Clermont-Ferrand, Clermont-Ferrand, France

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About this study

Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.

Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.

Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients over 18 years old
  • Active or Inactive Crohn's Disease
  • Previously enrolled in RAPID clinical trial

Exclusion criteria

  • Pregnant or nursing woman
  • Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
  • Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.

Treatment and study plan

Abdominal MRI

Procedure

Abdominal MRI to realize within 4 months following inclusion

Upper Endoscopy

Procedure

Upper endoscopy to realize within 4 months following inclusion

colonoscopy

Procedure

Colonoscopy to realize within 4 months following inclusion

Pelvic MRI

Procedure

Pelvic MRI to realize within 4 months following inclusion

Primary outcomes

  1. Digestive damage

    Time frame: 5 to 10 years after diagnosis

    Evaluate digestive damage in Crohn's Disease by using Lemann Index

Secondary outcomes

  1. Predictive factors of the digestive damage evolution

    Time frame: 5 to 10 years after diagnosis

    Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index

  2. Predictive factors of the digestive damage evolution

    Time frame: 5 to 10 years after diagnosis

    Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis.

  3. Variation of Lemann Index

    Time frame: 5 to 10 years after diagnosis

    Variation of Lemann Index 5 to 10 years after diagnosis

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Acronym: DESTIN

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2015
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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