Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 7:33 AM
Study NCT ID:
NCT01923103
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2013-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Disease Progress of Dupuytren Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}, {'id': 'D018450', 'term': 'Disease Progression'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 261}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2013-08-09', 'studyFirstSubmitQcDate': '2013-08-13', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The course of DD: passive and active extension deficit and dimension of palpable nodules and cords', 'timeFrame': 'every 6-12 months', 'description': 'Active and passive extension deficit is measured with a goniometer at joint level Dimension of nodules and cords is measured using a tumorimeter'}], 'secondaryOutcomes': [{'measure': 'Disease activity: Echogenicity and nodule hardness', 'timeFrame': 'every 12 months, starting from 2016 (ultrasound) and 2018 (tonometry)', 'description': 'Activity of a nodule is determined by 1) echogenicity of the ultrasound image in sagittal and transversal plane, 2) hardness of the nodule determined by tonometry'}, {'measure': 'Patient-reported hand function: MHQ, PRWHE and URAM', 'timeFrame': 'every 6-12 months', 'description': 'To study what problems patients with DD experience in daily life, PROMs are used. MHQ and PRWHE in the first 2 years, URAM later on'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dupuytren Contracture', 'Disease Progression']}, 'descriptionModule': {'briefSummary': 'Dupuytren disease (DD) is a progressive fibromatosis of the palmar fascias of the hand and fingers, which may lead to extension deficits of the fingers. The disease can be very disabling in moderate and severe cases, whereby performing normal daily activities can become very problematic. The aetiology and pathogenesis are not completely understood. There is a genetic disposition and it is influenced by environmental factors. The disease is especially prevalent in white males of Northern European descent above 50 years of age. There is paucity of knowledge about the natural progression of the disease. Several studies have been conducted on progression of disease and from these studies it becomes obvious that the disease is progressive over several years. However, in most studies only one moment of follow-up has taken place, so the course of the progression over time is unknown.\n\nThe aim of this study is to enhance our knowledge on the natural disease progression of DD at different stages.', 'detailedDescription': "Objective:\n\n* Primary objective: To study natural disease progress of Dupuytren Disease (DD) in different stages of disease in males and females above 18 years of age.\n* Secondary objectives:\n\n 1. To study the effect of potential risk factors for DD on natural disease progress.\n 2. To study at what stage of disease patients with DD experience problems in daily life.\n 3. To study the incidence and course of recurrent disease. Primary Hypothesis: The natural course of disease is an exponential function of time.\n 4. To study the intrarater reliability of the measurements\n\n f. To determine whether the echogenicity of the nodules can predict progression g. To determine whether extension deficit measurements can be replaced by measurements of extension, and whether this will facilitate the statistical analysis h. To determine the association between passive and active measurements of extension and extension deficit, and to see whether active measurements can be derived from passive measurements and vice versa.\n* Study design: The study is designed as a prospective observational pilot study with a follow-up of 10 years.\n* Study population: Males and females above 18 years of age with all stages of primary Dupuytren's disease in at least one hand\n* Main study parameters/endpoints: The natural course of progression of DD measured as the increase or decrease in size of nodules and cords in millimetres and/or increase of total passive extension deficit in degrees, from baseline to endpoint.\n* Secondary study parameters:\n\n 1. Patient-reported hand function (Michigan Hand Outcomes Questionnaire (MHOQ), Patient-Rated Wrist/Hand Evaluation (PRWHE) and Unité Rhumatologique des Affections de la Main (URAM) scale\n 2. incidence and course of recurrent disease\n 3. disease activity (ultrasonography and tonometry)\n* Procedure Patients visit the outpatient clinic every 6 months (first 5 years of follow-up) and later on every 12 months (last 5 years of follow-up) for an anamnestic interview, physical examination of the hands, ultrasonography, tonometry and for filling out the PROMs."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Dupuytren Disease who participated in prior studies and patients from the outpatient clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients (\\> 18 years of age) with primary Dupuytren's disease in all Tubiana stages\n* Operated hands of patients with primary Dupuytren's disease on the contra lateral hand\n\nExclusion Criteria:\n\n* Patients who are incapable of giving consent\n* Patients who are not able or not willing to visit the UMCG for follow-up\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule"}, 'identificationModule': {'nctId': 'NCT01923103', 'acronym': 'DD', 'briefTitle': 'Natural Disease Progress of Dupuytren Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Natural Disease Progress of Dupuytren Disease', 'orgStudyIdInfo': {'id': 'NDPDD'}}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Paul MN Werker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan available, but we are open for collaboration'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'D.C. Broekstra', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}