Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-26 @ 8:36 AM
Study NCT ID:
NCT04972604
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CureDuchenne Link®: A Resource for Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Urine, Saliva, Muscle and Skin will be collected. Sample collection will be optional.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2031-07-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-12', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-07-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis', 'timeFrame': 'Upon study entry', 'description': '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'}, {'measure': 'Genetic Mutation', 'timeFrame': 'Upon study entry or when genetic testing results are available', 'description': 'Participants will be asked to provide genetic testing reports confirming their diagnosis, where available, which will be reviewed by a central genetic counselor.'}], 'secondaryOutcomes': [{'measure': 'Functional Status', 'timeFrame': 'Upon study entry and every 6-12 months thereafter for up to ten (10) years', 'description': 'Self reported data (questionnaire on ambulation and mobility) will be captured'}, {'measure': 'North Star Ambulation Assessment (NSAA) Score', 'timeFrame': 'Upon study entry and every 6-12 months thereafter for up to ten (10) years', 'description': 'Clinically reported NSAA scores will be captured'}, {'measure': '6 Minute Walk Test (6MWT) Score', 'timeFrame': 'Upon study entry and every 6-12 months thereafter for up to ten (10) years', 'description': 'Clinically reported 6MWT scores will be captured'}, {'measure': 'Corticosteroid Status', 'timeFrame': 'Upon study entry and every 6-12 months thereafter for up to ten (10) years', 'description': 'Self reported and clinically reported corticosteroid status (past and present) will be captured'}, {'measure': 'Cardiac Status', 'timeFrame': 'Upon study entry and every 6-12 months thereafter for up to ten (10) years', 'description': 'Self reported and clinically reported cardiac status (past and present) will be captured'}, {'measure': 'Respiratory Status', 'timeFrame': 'Upon study entry and every 6-12 months thereafter for up to ten (10) years', 'description': 'Self reported and clinically reported respiratory status (past and present) will be captured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carrier', 'DMD', 'BMD'], 'conditions': ['Duchenne Muscular Dystrophy', 'Becker Muscular Dystrophy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cureduchenne.org/cureduchenne-link/', 'label': 'CureDuchenne Link Information Page'}, {'url': 'https://cureduchennelink.org/', 'label': 'CureDuchenne Link Registration Page'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'Individuals can participate through the CureDuchenne Link™ application (accessible via mobile device or web interface) and receive communications about research opportunities and community programs. Participation may be done using virtual methods, at a project site, and/or at community events nationwide.\n\nAll collected information will be stored in a secure, HIPAA-compliant data warehouse for approved researchers to use for studies relevant to DMD, BMD and other neuromuscular disorders. Combining health and outcomes data with biospecimens provides an impactful solution and novel resource for researchers, allowing for effective translational research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with or carriers of Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any of the following are true:\n\n 1. Currently has a confirmed diagnosis of DMD/BMD based on genetic testing, muscle biopsy, or clinical diagnosis.\n 2. Currently has a confirmed diagnosis of carrier status for DMD/BMD based on genetic testing.\n2. Parent/guardian (for minor participants) or participant gives informed consent and/or assent as required by local regulations.\n3. Is age 4 weeks or older at the time of consent.\n\nExclusion Criteria:\n\n1. Is a foster child or ward of the state.\n2. Is a prisoner.'}, 'identificationModule': {'nctId': 'NCT04972604', 'acronym': 'CDLink', 'briefTitle': 'CureDuchenne Link®: A Resource for Research', 'organization': {'class': 'OTHER', 'fullName': 'CureDuchenne'}, 'officialTitle': 'CureDuchenne Link®: A Resource to Support Research Studies in Duchenne and Becker Muscular Dystrophy (DMD/BMD)', 'orgStudyIdInfo': {'id': 'CD-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Duchenne and Becker muscular dystrophy', 'description': 'Individuals with Duchenne muscular dystrophy and Becker muscular dystrophy'}, {'label': 'Carriers', 'description': 'Carriers of Duchenne muscular dystrophy and Becker muscular dystrophy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aravindhan Veerapandiyan, MD', 'role': 'CONTACT', 'email': 'aveerapandiyan@uams.edu', 'phone': '501-364-7373'}], 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'CD Link Staff', 'role': 'CONTACT', 'email': 'support@cureduchennelink.org', 'phone': '888-235-4655'}, {'name': 'Debra Miller', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CureDuchenne', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Linda Do', 'role': 'CONTACT', 'email': 'linh.do@choc.org', 'phone': '714-509-8945'}, {'name': 'Amanda Fernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julia Zhu', 'role': 'CONTACT', 'email': 'julia.zhu@rarediseaseresearch.com'}, {'name': 'Han Phan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rare Disease Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katherine Matthews', 'role': 'CONTACT', 'email': 'katherine-matthews@uiowa.edu'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cassidy Nelson', 'role': 'CONTACT', 'email': 'cnelson15@kumc.edu'}, {'name': 'Jeffrey Statland, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kansas University Clinical Research Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abby Setterington', 'role': 'CONTACT', 'email': 'abigail.setterington@corewellhealth.org'}, {'name': 'Jena Krueger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Corewell Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '27278', 'city': 'Hillsborough', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annette Babu', 'role': 'CONTACT', 'email': 'annette.babu@rarediseaseresearch.com'}, {'name': 'Edward Smith', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rare Disease Research Center', 'geoPoint': {'lat': 36.07542, 'lon': -79.09973}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Stoute', 'role': 'CONTACT', 'email': 'estoute@pennstatehealth.psu.edu'}, {'name': 'Ashutosh Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Penn State Health', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '76208', 'city': 'Denton', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Guillermo Saldaña', 'role': 'CONTACT', 'email': 'guillermo.saldana@Neuromdcenter.com'}, {'name': 'Diana Castro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurology Rare Disease Center', 'geoPoint': {'lat': 33.21484, 'lon': -97.13307}}], 'centralContacts': [{'name': 'Erica Rudoff', 'role': 'CONTACT', 'email': 'support@cureduchennelink.org', 'phone': '888-235-4655'}], 'overallOfficials': [{'name': 'Debra Miller', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CureDuchenne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After a thorough application process, data will be shared to qualified researchers.\n\nApproved researchers will complete all required CDA/data transfer agreements with CureDuchenne. Once complete, they will be given access to a limited dataset with direct identifiers removed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CureDuchenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}