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Development and Validation of a Comorbidity Index in Crohn's Disease (NEMO-Index)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05253378
Recruitment Status : Not yet recruiting
First Posted : February 23, 2022
Last Update Posted : February 23, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France

Brief Summary:
Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD). Like other chronic diseases, patients with CD may be affected by other diseases called comorbidities. The prevalence of comorbidities in IBD patients ranges from 30 to 70 %. Unlike other chronic diseases, there is currently no CD-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. Several clinical indexes have been developed for the study of comorbidities, including the Charlson index and the Groll index, which are widely used. The disadvantage of these indexes is that they are not adapted to patients with CD. The primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD.

Condition or disease
Crohn Disease

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of a Comorbidity Index in Crohn's Disease
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease




Primary Outcome Measures :
  1. To develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with CD. [ Time Frame: Through study completion, an average of 3 years ]
    Probability of having an IBD disability index ≥ 35 (i.e. moderate and severe disability).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CD patients
Criteria

Inclusion Criteria:

  1. Patients between 18 and 59 years old
  2. Established diagnosis of CD with a minimum disease duration of 3 months
  3. Disease considered by the treating gastroenterologist to have been stable for at least 3 months

Exclusion Criteria:

  1. Subject unable to comply with study procedures
  2. Surgery for CD 3 months prior to inclusion visit

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): NCT05253378


Locations
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France
CHRU Nancy
Vandoeuvre-lès-Nancy, France
Contact: Laurent Peyrin-Biroulet, MD, PhD         
Italy
San Raffaele Hospital
Milano, Italy
Contact: Silvio Danese, MD, PhD         
Sponsors and Collaborators
Central Hospital, Nancy, France
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Responsible Party: Dr Laurent PEYRIN-BIROULET, MD, PhD, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT05253378    
Other Study ID Numbers: 2021PI158
First Posted: February 23, 2022    Key Record Dates
Last Update Posted: February 23, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases