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Trial record 5 of 2086 for:    Recruiting, Not yet recruiting, Available Studies | "Intestinal Diseases"

Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2008). (Inspired)

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ClinicalTrials.gov Identifier: NCT02392221
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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. These are diseases of multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD registry, the world's largest epidemiological register for IBD, identifying all incident cases in the four departments of the North West of France showed between 1988 and 2007, an increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p <0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The increase in the incidence of CD will contribute to increase its weight in the health system, particularly in the pediatric CD frequently associated with an aggressive phenotype causing specific complications such as malnutrition, pubertal delay or thrive. These complications have a important impact on the quality of life with a long-term risk of functional disability. They may be associated with increased mortality. Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have profoundly changed the management of pediatric IBD. Although there is little data on the impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission. With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal healing and more recently the deep remission combining clinical remission, biological and endoscopic, appears. However there is no data in the general population assessing the impact of new treatments and new therapeutic strategies in the pediatric population. Potential risks associated with the increasing use and early use of biological treatments in this particular population remain to be determined in the general population.

The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed before 17 yeras old could influence the cumulative incidence of surgical resection and complications specific to this population as failure to thrive and delayed puberty, insertion socio-professional, the extension of the disease, hospitalization rates, and the rate of cancer.


Condition or disease
Pediatric Inflammatory Bowel Disease

Detailed Description:

Crohn's disease (CD) and ulcerative colitis (UC) are chronic Inflammatory Bowel Disease (IBD) and may affect all segments of the digestive tract. These are diseases of multifactorial origin in which environmental and genetic factors are predominant.The EPIMAD registry, the world's largest epidemiological register for IBD, identifying all incident cases in the four departments of the North West of France showed between 1988 and 2007, an increase in the annual incidence of MC 71 % (6.5 / 105 (1988-1990) 11.1 / 105 (2006-2007) p <0.0001) in the age group 10-19 years. At the same time, the annual incidence of UC decreased 4.3 / 3.5 105 inhabitants / 105 inhabitants (20%), with phenotypic presentation remained stable. The increase in the incidence of CD will contribute to increase its weight in the health system, particularly in the pediatric CD frequently associated with an aggressive phenotype causing specific complications such as malnutrition, pubertal delay or thrive. These complications have a important impact on the quality of life with a long-term risk of functional disability. They may be associated with increased mortality. Immunosuppressants (azathioprine, methotrexate) have been used in pediatric forms only from the 90s and anti-TNF antibodies (infliximab and adalimumab), until the 2000s. These new therapeutic classes have profoundly changed the management of pediatric IBD. Although there is little data on the impact of these new treatments, early introduction of immunosuppressive and anti-TNFs seems to influence the natural history of IBD diagnosed in pediatric age. Anti-TNFs appear to be associated with more frequent and deeper remission. With the advent of these new treatment, new therapeutic targets such as endoscopic mucosal healing and more recently the deep remission combining clinical remission, biological and endoscopic, appears. However there is no data in the general population assessing the impact of new treatments and new therapeutic strategies in the pediatric population. Potential risks associated with the increasing use and early use of biological treatments in this particular population remain to be determined in the general population.

The main hypothesis of this study is that changes in therapeutic strategies in IBD diagnosed before 17 yeras old could influence the cumulative incidence of surgical resection and complications specific to this population as failure to thrive and delayed puberty, insertion socio-professional, the extension of the disease, hospitalization rates, and the rate of cancer.


Study Type : Observational
Estimated Enrollment : 966 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Therapeutic Strategies in the Pediatric Inflammatory Bowel Disease: a Population Based Study (1988-2008).
Study Start Date : May 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019



Primary Outcome Measures :
  1. Cumulative incidence of surgical resection in CD and colectomy in pediatric UC [ Time Frame: end of follow up ]
    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.


Secondary Outcome Measures :
  1. Disease extension according to Montreal classification [ Time Frame: end of follow up ]
    Phenotype of MICI maximum monitoring (Montreal classification), according to the date of diagnosis

  2. Treatment during the follow up [ Time Frame: end of follow up ]
  3. information about occurrence of postoperative complications [ Time Frame: end of follow up ]
    Presence, date and type of occurrence of postoperative complications (Dindo classification).

  4. Weight and size at diagnosis, at the first intestinal resection and at the end of follow up [ Time Frame: end of follow up ]
  5. Hospitalisations: number, duration, date [ Time Frame: end of follow up ]
  6. Studies category Socio-Professional [ Time Frame: end of follow up ]
    Studies category Socio-Professional (CSP) and occupation

  7. Age of puberty [ Time Frame: end of follow up ]
    Age of puberty

  8. Death [ Time Frame: end of follow up ]
    Death and if so; due date and

  9. Serious infectious complications and cancer [ Time Frame: end of follow up ]


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Ages Eligible for Study:   up to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric IBD patients in the area of EPIMAD registry Age of diagnosis < 17 years
Criteria

Inclusion Criteria:

Patients in the pediatric cohort EPIMAD registry with a diagnosis of CD or UC or probable between 1988 and 2008.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392221


Contacts
Contact: Mathurin Fumery, Doctor 322668214 ext +33 mathurinf@hotmail.fr
Contact: Jean Louis DUPAS, professor 322668214 ext +33 dupas.jean-louis@chu-amiens.fr

Locations
France
CHRU Lille Recruiting
Lille, France, 59000
Contact: Gower Rousseau, Doctor    320445518 ext +33      
Principal Investigator: Corinne Gower-Rousseau, Doctor         
Sub-Investigator: Luc Dauchet, Doctor         
CHU Rouen Not yet recruiting
Rouen, France, 7700
Contact: Eric Lerebours, professor    232888101 ext +33      
Contact: Lerebours , professor    232888101 ext +33      
Sub-Investigator: guillaume Savoye, professor         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Director: Mathurin Fumery, Doctor CHU Amiens France
Study Director: Jean-Louis Dupas, professor CHU Amiens France

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02392221     History of Changes
Other Study ID Numbers: PI2013_843_0022
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Crohn's disease (CD)
Pediatric
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis