The overall objectives of this proposal are to develop two indices capable of measuring intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's disease by means of Magnetic Resonance Imaging with Enterography…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To develop an MRI-based index for assessment of intestinal damage in
pediatric Crohn's disease (pMEDIC) , using robust psychometric and clinimetric
methods
2. To develop an MRI-based index of radiologist reported signs of bowel
inflammation/bowel inflammation in pediatric Crohn's disease (PICMI), using
robust psychometric and clinimetric methods
3. To evaluate both indices for their clinimetric properties, including
reliability, validity and responsiveness
Secondary outcome
1. To descibe the 18-month progression rate of intestinal damage in pediatric
Crohn's disease, stratified by the different medications used, and disease
duration at enrolment
2. To identify biological and clinical markers, predictive of intestinal damage
Background summary
Novel biologic therapies may be effective in achieving mucosal healing in
Crohn's disease (CD), thereby reducing the long term risk for damage to the
bowel, including stenosis and fistulas. However, at present there is no tool by
which to measure intestinal damage and thus clinical trials of emerging novel
therapies do not report the ability of the drug to change the natural history
of the disease. In clinical practice, the rate of progression of damage has not
been described in children, in part because accurate longitudinal reassessment
of damage has not been possible. MR Enterography (MRE) can estimate both the
intestinal inflammation and the degree of damage, but there is no validated
scoring system for that modality. Currently, the IPNIC group is in the midst of
developing a damage score in adults (called the Lemann score). Crohn's disease
presents during childhood in up to 25% of cases, when it tends to be more
extensive and may have a more aggressive disease course than in adults.
Moreover, repeated endoscopic assessment and radiation-related imaging are
considered less acceptable in children, notions that should be emphasized when
developing scoring systems for children.
Study objective
The overall objectives of this proposal are to develop two indices capable of
measuring intestinal damage, and, separately, inflammatory disease activity in
Pediatric Crohn's disease by means of Magnetic Resonance Imaging with
Enterography protocol (MRE).
The indices are aimed to be discriminative (at one point in time), evaluative
(measuring damage progression over time) and predictive. The indices will be
used as endpoint measures in clinical research and also in clinical practive to
identify those who are at risk for rapid disease progression and surgery.
Study design
This is a longitudinal, prospective, multicenter, observational, cohort study
in which a diversity of clinical parameters will be examined.
At inclusion in the study an MRE and gastroscopy and ileocolonoscopy wil be
performed as standard patient care. In addition blood, urine and stool samples
wil be collected and clinical parameters, growth and quality of life will be
evaluated. The follow-up period will be 1.5 years, after which a repeated MRE
will be performed. At 6 and 12 months after enrollment, a visit to the
outpatient clinic will take place during which clinical and growth parameters
will be collected and blood samples will be taken.
The management of patients will be dictated according to the discretion of the
caring physician and not by this protocol.
Study burden and risks
The procedures involved in this study are almost all part of routine clinical
care. The MRE scan and colonoscopy/upper endoscopy will not be different if
the child does not participate in this study. The added procedures for the
study will be a quality of life survey and the second MRE after 18 months. For
the MRE scan, a venous catheter must be placed, oral contrast must be taken and
the child has to lie stil for about 45 minutes. This can be a burden for the
patient. The quality of life survey will add a few minutes to 2 of the visits.
The risk of all procedures are very low.
It is expected that the treatment of the individual patient can be optimized by
using the new indices and by performing the second MRE scan. Nowadays, it is
not current practice to perform a standard follow-up MRE in children with
Crohn's disease without clinical complaints. Considering the risk of developing
damage without actual complaints, however, this current practice may not be the
best for the patient. The future use of the newly developed validated pMEDIC en
PICMI scores based on MRE will make it unnessary to perform repeated
colonoscopies, which is beneficial to the child.
Bayit Street 12
Jerusalem 91031
IL
Bayit Street 12
Jerusalem 91031
IL
Listed location countries
Age
Inclusion criteria
- Children from age 5 (under 18 years of age) with established diagnosis of Crohn's disease involving any location, by the presence of accepted clinical, radiologic, endoscopic and histological criteria
- enrolment at the time of performing ileocolonoscopy and esophageal-gastroduodenoscopy (EGD) as part of clinical care for any reason
- Children will be enrolled at any phase of the disease (at diagnosis and thereafter as required clinically). In order to ensure enough subjects with intestinal damage and since damage is progressing over time, enrolment will be stratified based on disease duration. Enrolment for each stratum of disease duration will be closed after reaching the expected sample size
* 20% of enrolment children will be within 3 months of diagnosis
* 20% of children will be between 3 months and 2 years
* 20% will be 2 to 3 years
* 40% will have disease duration over 3 years
- Children may be enrolled in any disease activity state, Pediatric Crohn's Disease Activity Index (PCDAI) between 0 and 100.
Exclusion criteria
- Young children requiring anesthesia for the MRE because of lack of cooperation will be excluded (since the enteric contrast cannot be administered during the 2 hours before anesthesia and it is crucial that the contrast be given just prior the test)
- For the first 120 children only, subjects who are not expected to be available for 18 months follow-up, will be excluded (the last 120 subjects may be enrolled as they are not followed longitudinally)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01881490 |
| CCMO | NL43209.078.13 |