Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis (DESTIN)
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Abdominal MRI
Upper endoscopy
Colonoscopy
Pelvic MRI
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Digestive Damage, Lemann Index
Eligibility Criteria
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.
Sites / Locations
- Chu Clermont-Ferrand
- Hopital Beaujon
- CHRU Lille
- CHU NICE
- Hopital Saint Louis
- Hopital Saint-Antoine
- IMM
- CHU Bordeaux - Pessac
- Chu Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation group
Arm Description
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations. All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations : Upper tract location : upper endoscopy Colorectal location : colonoscopy Perianal location : pelvic MRI All patients : abdominal MRI
Outcomes
Primary Outcome Measures
Digestive damage
Evaluate digestive damage in Crohn's Disease by using Lemann Index
Secondary Outcome Measures
Predictive factors of the digestive damage evolution
Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
Predictive factors of the digestive damage evolution
Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis.
Variation of Lemann Index
Variation of Lemann Index 5 to 10 years after diagnosis
Full Information
NCT ID
NCT02549976
First Posted
September 11, 2015
Last Updated
July 30, 2018
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
1. Study Identification
Unique Protocol Identification Number
NCT02549976
Brief Title
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
Acronym
DESTIN
Official Title
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, Digestive Damage, Lemann Index
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation group
Arm Type
Experimental
Arm Description
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations.
All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
Upper tract location : upper endoscopy
Colorectal location : colonoscopy
Perianal location : pelvic MRI
All patients : abdominal MRI
Intervention Type
Procedure
Intervention Name(s)
Abdominal MRI
Intervention Description
Abdominal MRI to realize within 4 months following inclusion
Intervention Type
Procedure
Intervention Name(s)
Upper endoscopy
Intervention Description
Upper endoscopy to realize within 4 months following inclusion
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Colonoscopy to realize within 4 months following inclusion
Intervention Type
Procedure
Intervention Name(s)
Pelvic MRI
Intervention Description
Pelvic MRI to realize within 4 months following inclusion
Primary Outcome Measure Information:
Title
Digestive damage
Description
Evaluate digestive damage in Crohn's Disease by using Lemann Index
Time Frame
5 to 10 years after diagnosis
Secondary Outcome Measure Information:
Title
Predictive factors of the digestive damage evolution
Description
Evaluate digestive damage per organ (upper intestinal tract, small bowel, colon or rectum, anal or perianal) by using Lemann Index
Time Frame
5 to 10 years after diagnosis
Title
Predictive factors of the digestive damage evolution
Description
Determine correlation between Lemann Index and factors measured at diagnosis and then 5 to 10 years after diagnosis.
Time Frame
5 to 10 years after diagnosis
Title
Variation of Lemann Index
Description
Variation of Lemann Index 5 to 10 years after diagnosis
Time Frame
5 to 10 years after diagnosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Pariente, MD, PhD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Cosnes, MD
Organizational Affiliation
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Clermont-Ferrand
City
Clermont-ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHRU Lille
City
Lille
Country
France
Facility Name
CHU NICE
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
IMM
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Bordeaux - Pessac
City
Pessac
ZIP/Postal Code
33700
Country
France
Facility Name
Chu Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25241327
Citation
Pariente B, Mary JY, Danese S, Chowers Y, De Cruz P, D'Haens G, Loftus EV Jr, Louis E, Panes J, Scholmerich J, Schreiber S, Vecchi M, Branche J, Bruining D, Fiorino G, Herzog M, Kamm MA, Klein A, Lewin M, Meunier P, Ordas I, Strauch U, Tontini GE, Zagdanski AM, Bonifacio C, Rimola J, Nachury M, Leroy C, Sandborn W, Colombel JF, Cosnes J. Development of the Lemann index to assess digestive tract damage in patients with Crohn's disease. Gastroenterology. 2015 Jan;148(1):52-63.e3. doi: 10.1053/j.gastro.2014.09.015. Epub 2014 Sep 21.
Results Reference
background
PubMed Identifier
23644079
Citation
Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30.
Results Reference
background
Links:
URL
http://www.getaid.org
Description
Related Info
Learn more about this trial
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
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