Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-27 @ 6:44 PM
Study NCT ID:
NCT05877066
Status:
TERMINATED
Last Update Posted:
2024-04-16
First Post:
2023-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Endo determined to discontinue its registries and the GRASP registry enrollment has been closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-13', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Receiving Each Treatment Type for DC', 'timeFrame': 'Up to 36 months'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Michigan Hand Questionnaire (MHQ) Scale Score', 'timeFrame': 'Up to 36 months'}, {'measure': 'Change from Baseline in European Quality of Life Five Dimension (EQ-5D) Questionnaire Score', 'timeFrame': 'Up to 36 months'}, {'measure': 'Change from Baseline in Unité Rhumatologique des Affections de la Main (URAM) Scale Score', 'timeFrame': 'Up to 36 months'}, {'measure': 'Participant Satisfaction Questionnaire', 'timeFrame': 'Up to 36 months'}, {'measure': 'Number of Participants Receiving Post-Procedural Care by the Treating Physician', 'timeFrame': 'Up to 36 months'}]}, 'conditionsModule': {'keywords': ['Real world data', 'Retrospective', 'Prospective', 'Registry'], 'conditions': ["Dupuytren's Contracture"]}, 'descriptionModule': {'briefSummary': "This is an observational study, meaning participants will not receive any investigational treatment as part of this study.\n\nResearchers will collect real-world data (RWD), based on usual care, to gain a more in-depth knowledge of the natural history and the treatment outcomes of Dupuytren's Contracture (DC) to evaluate the management of DC.", 'detailedDescription': "Each participant of the study will have their data collected from the date of confirmed diagnosis of DC to the date of enrollment in the registry, post consent. Data will be collected from the participants clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a confirmed diagnosis of DC will be enrolled in the United States.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Any adult with a confirmed clinical diagnosis of DC.\n* Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.\n* Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.\n* Having received DC treatment, either non-surgical or surgical, within 2 weeks before enrollment, at enrollment or any time after the date of enrollment or not having received DC treatment after confirmed diagnosis of DC.\n* Able to participate in English based registry.\n\nKey Exclusion criteria:\n\n* Not having a clinical diagnosis of DC.\n* Age less than 18 years.\n* Do not provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05877066', 'acronym': 'GRASP-DC', 'briefTitle': "Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture", 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': "Generating Real-world Ambispective Data to Study Participant Treatment Outcomes for Dupuytren's Contracture", 'orgStudyIdInfo': {'id': 'EP01REG'}}, 'contactsLocationsModule': {'locations': [{'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 6', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06831', 'city': 'Greenwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 5', 'geoPoint': {'lat': 41.02649, 'lon': -73.62846}}, {'zip': '33637', 'city': 'Temple Terrace', 'state': 'Florida', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 4', 'geoPoint': {'lat': 28.0353, 'lon': -82.38926}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 2', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '07774', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 1', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 7', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97701', 'city': 'Bend', 'state': 'Oregon', 'country': 'United States', 'facility': 'Endo Pharmaceuticals Clinical Site 3', 'geoPoint': {'lat': 44.05817, 'lon': -121.31531}}], 'overallOfficials': [{'name': 'Medical Information', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Endo Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Endo Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pulse Infoframe', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}