Duchenne Muscular DystrophyDIGDNCT04384354
Digestive Events in Duchenne Muscular Dystrophy Patients
An observational study of Duchenne Muscular Dystrophy, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Apr 2019
- Phase
- Observational
- 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 15 years and older
- Men only
- Child, Adult, Older adult
Study population: Duchenne muscular dystrophy patients
Who may be able to join
- all Duchenne muscular dystrophy patients in our center
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Relation between clinical and genetic features and acute digestive events in Duchenne muscular dystrophy patients
Read the 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)
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- pseudo occlusion, gastrostomy
- Medical subject headings
- Muscular Dystrophy, Duchenne
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of digestive events
Clinical parameters (yes or no): gastrostomy, bowel occlusion, acute gastric paresia, biliary complication
Measured: 11 years
Prevalence of digestive events
Clinical parameters (yes or no) : gastrostomy, bowel occlusion, acute gastric paresia, biliary complication
Measured: 11 years
Risk factors for digestive events (1)
age (years)
Measured: 11 years
Risk factors for digestive events (2)
pulmonary functional tests (vital capacity in ml/kg)
Measured: 11 years
Risk factors for digestive events (3)
echocardiography parameters (LVEF: left ventricular ejection fraction in %)
Measured: 11 years
Risk factors for digestive events (4)
residual dystrophin level (Western blot and/or immunohistochemistry in muscle)
Measured: 11 years
Risks factors for digestive events (5)
genetic parameters (type of mutation, functional domain of altered dystrophin)
Measured: 11 years
Secondary outcomes (2)
Nutritional status (1)
Weigh (kg) and height (in m) agregated in BMI (kg/m^2)
Measured: 11 years
Nutritional status (2)
albuminemia in g/L
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study startJan 2007
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular DystrophyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crenn, Centre d'Investigation Clinique et Technologique 805
- Investigators
- CICIT805 Garches, Study chair, APHP/UVSQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384354
- Sponsor's protocol ID
- DIGDMD
- Acronym
- DIGD
- Status last verified
- May 2020
- First submitted
- 19 Jul 2019
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All clinician and biologist involved in the follow-up of these patients
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestive Events in Duchenne Muscular Dystrophy Patients
- ClinicalTrials.gov ID
- NCT04384354
- Acronym / sponsor ID
- DIGD / DIGDMD
- Conditions
- Duchenne Muscular Dystrophy
- Keywords
- pseudo occlusion, gastrostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- Jan 2007 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 12 May 2020 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Duchenne muscular dystrophy patients
Key inclusion criteria (1 listed)
- all Duchenne muscular dystrophy patients in our center
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Nutritional status (1)
Time frame: 11 years
Nutritional status (2)
Time frame: 11 years
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 12 May 2020.
- Individual participant dataSharing planned: Undecided. All clinician and biologist involved in the follow-up of these patients
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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.
CICIT805 Garches study chair
APHP/UVSQ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duchenne Muscular Dystrophy, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 1 inclusion and 1 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of digestive events (time frame: 11 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.