CureDuchenne Link®: A Resource for Research
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorCureDuchenne
About this trial
CureDuchenne link is a data hub comprised of integrated biospecimens, clinical data, and self- and/or caregiver-reported information from participants. Anyone over 4 weeks old who has been diagnosed with DMD or BMD or who is a carrier of DMD or BMD can join. Parents or legal guardians can sign up their child(ren).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently has a confirmed diagnosis of DMD/BMD based on genetic testing, muscle biopsy, or clinical diagnosis.
Currently has a confirmed diagnosis of carrier status for DMD/BMD based on genetic testing.
Parent/guardian (for minor participants) or participant gives informed consent and/or assent as required by local regulations.
Is age 4 weeks or older at the time of consent.
Disqualifiers
Is a foster child or ward of the state.
Is a prisoner.
Trial population
Individuals with or carriers of Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 2 trial groupsGroup A: Duchenne and Becker muscular dystrophy
Group B: Carriers
Trial outcomes
Primary outcomes
1
Diagnosis
There is no intervention in this project. Participants will provide documentation to support their diagnosis of Duchenne muscular dystrophy, Becker muscular dystrophy, or a carrier of these mutations
Time frame
Upon study entry2
Genetic Mutation
Participants will be asked to provide genetic testing reports confirming their diagnosis, where available, which will be reviewed by a central genetic counselor.
Time frame
Upon study entry or when genetic testing results are availableSecondary outcomes
1
Functional Status
Self reported data (questionnaire on ambulation and mobility) will be captured
Time frame
Upon study entry and every 6-12 months thereafter for up to ten (10) years2
North Star Ambulation Assessment (NSAA) Score
Clinically reported NSAA scores will be captured
Time frame
Upon study entry and every 6-12 months thereafter for up to ten (10) years3
6 Minute Walk Test (6MWT) Score
Clinically reported 6MWT scores will be captured
Time frame
Upon study entry and every 6-12 months thereafter for up to ten (10) years4
Corticosteroid Status
Self reported and clinically reported corticosteroid status (past and present) will be captured
Time frame
Upon study entry and every 6-12 months thereafter for up to ten (10) yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov