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Digestive Events in Duchenne Muscular Dystrophy Patients (DIGD)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384354
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Crenn, Centre d'Investigation Clinique et Technologique 805

Tracking Information
First Submitted Date July 19, 2019
First Posted Date May 12, 2020
Last Update Posted Date May 12, 2020
Actual Study Start Date January 2007
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2020)
  • Incidence of digestive events [ Time Frame: 11 years ]
    Clinical parameters (yes or no): gastrostomy, bowel occlusion, acute gastric paresia, biliary complication
  • Prevalence of digestive events [ Time Frame: 11 years ]
    Clinical parameters (yes or no) : gastrostomy, bowel occlusion, acute gastric paresia, biliary complication
  • Risk factors for digestive events (1) [ Time Frame: 11 years ]
    age (years)
  • Risk factors for digestive events (2) [ Time Frame: 11 years ]
    pulmonary functional tests (vital capacity in ml/kg)
  • Risk factors for digestive events (3) [ Time Frame: 11 years ]
    echocardiography parameters (LVEF: left ventricular ejection fraction in %)
  • Risk factors for digestive events (4) [ Time Frame: 11 years ]
    residual dystrophin level (Western blot and/or immunohistochemistry in muscle)
  • Risks factors for digestive events (5) [ Time Frame: 11 years ]
    genetic parameters (type of mutation, functional domain of altered dystrophin)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 11, 2020)
  • Nutritional status (1) [ Time Frame: 11 years ]
    Weigh (kg) and height (in m) agregated in BMI (kg/m^2)
  • Nutritional status (2) [ Time Frame: 11 years ]
    albuminemia in g/L
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Digestive Events in Duchenne Muscular Dystrophy Patients
Official Title Digestive Events in Duchenne Muscular Dystrophy Patients
Brief Summary Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients
Detailed Description Clinical Data of the disease Digestive events (pseudo occlusion, gastrostomy, cholecystectomy) Nutritionnal parameters Genetic of dystrophin (approved genetic nationnal Data base, CHU Cochin, Paris France)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood samples
Sampling Method Non-Probability Sample
Study Population Duchenne muscular dystrophy patients
Condition Duchenne Muscular Dystrophy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 11, 2020)
200
Original Actual Enrollment Same as current
Actual Study Completion Date April 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all Duchenne muscular dystrophy patients in our center

Exclusion Criteria:

  • none
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Only male patients, due to the specific disease (Duchenne muscular dystrophy patients)
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04384354
Other Study ID Numbers DIGDMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: All clinician and biologist involved in the follow-up of these patients
Responsible Party Crenn, Centre d'Investigation Clinique et Technologique 805
Study Sponsor Centre d'Investigation Clinique et Technologique 805
Collaborators Not Provided
Investigators
Study Chair: CICIT805 Garches APHP/UVSQ
PRS Account Centre d'Investigation Clinique et Technologique 805
Verification Date May 2020