Crohn's DiseaseDESTINNCT02549976
Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
A study testing Abdominal MRI, Upper endoscopy and Colonoscopy in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Abdominal MRI, Upper endoscopy and Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 9 sitesFrance
- Study dates
- Dec 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients over 18 years old
- Active or Inactive Crohn's Disease
- Previously enrolled in RAPID clinical trial
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Hopital Beaujon
Clichy, 92110
CHRU Lille
Lille
CHU NICE
Nice, 06202
Hopital Saint Louis
Paris, 75010
Hopital Saint-Antoine
Paris, 75012
IMM
Paris, 75014
CHU Bordeaux - Pessac
Pessac, 33700
Chu Toulouse
Toulouse, 31403
About this study
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Abdominal MRI, Upper endoscopy, Colonoscopy, Pelvic MRI
- Keywords
- Crohn's Disease, Digestive Damage, Lemann Index
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MRIProcedure or surgery
Abdominal MRI to realize within 4 months following inclusion
Upper endoscopyProcedure or surgery
Upper endoscopy to realize within 4 months following inclusion
ColonoscopyProcedure or surgery
Colonoscopy to realize within 4 months following inclusion
Pelvic MRIProcedure or surgery
Pelvic MRI to realize within 4 months following inclusion
| Study group | Role | What they receive |
|---|---|---|
| Evaluation group | Experimental | 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 Receives: Procedure: Abdominal MRI; Procedure: Upper endoscopy; Procedure: Colonoscopy; Procedure: Pelvic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digestive damage
Evaluate digestive damage in Crohn's Disease by using Lemann Index
Measured: 5 to 10 years after diagnosis
Secondary outcomes (3)
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
Measured: 5 to 10 years after diagnosis
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.
Measured: 5 to 10 years after diagnosis
Variation of Lemann Index
Variation of Lemann Index 5 to 10 years after diagnosis
Measured: 5 to 10 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Pariente, MD, PhD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesJacques Cosnes, MD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549976
- Sponsor's protocol ID
- 2015-4
- Acronym
- DESTIN
- Status last verified
- Jul 2018
- First submitted
- 11 Sep 2015
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25241327Cosnes 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.
PubMed 23644079
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
- ClinicalTrials.gov ID
- NCT02549976
- Acronym / sponsor ID
- DESTIN / 2015-4
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Digestive Damage, Lemann Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation group | Experimental | Procedure: Abdominal MRI, Procedure: Upper endoscopy, Procedure: Colonoscopy, Procedure: Pelvic MRIDigestive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients over 18 years old
- Active or Inactive Crohn's Disease
- Previously enrolled in RAPID clinical trial
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal MRIAbdominal MRI to realize within 4 months following inclusion | Procedure or surgery | Evaluation group |
| Upper endoscopyUpper endoscopy to realize within 4 months following inclusion | Procedure or surgery | Evaluation group |
| ColonoscopyColonoscopy to realize within 4 months following inclusion | Procedure or surgery | Evaluation group |
| Pelvic MRIPelvic MRI to realize within 4 months following inclusion | Procedure or surgery | Evaluation group |
Primary outcome
Digestive damage
Time frame: 5 to 10 years after diagnosis
Evaluate digestive damage in Crohn's Disease by using Lemann Index
3 secondary outcomes
Predictive factors of the digestive damage evolution
Time frame: 5 to 10 years after diagnosis
Predictive factors of the digestive damage evolution
Time frame: 5 to 10 years after diagnosis
Variation of Lemann Index
Time frame: 5 to 10 years after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Background: PubMed 25241327Pariente 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.
- Background: PubMed 23644079Cosnes 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Pariente, MD, PhD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Jacques Cosnes, MD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal MRI, Upper endoscopy and Colonoscopy in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digestive damage (time frame: 5 to 10 years after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549976, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.