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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02983162
Other study ID # 201600670
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2017
Est. completion date August 1, 2018

Study information

Verified date February 2022
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a significant association between the weighted genetic risk score and Dupuytren disease recurrence. However, a significant dose-response relation was not found. This might be caused by underestimating the recurrence rate, due to the retrospective nature of determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to see whether they suffered from recurrent disease. Objective: We aim to determine whether the wGRS is associated with recurrent DD. Study design: An observational study, in which the participants of the GODDAF study are followed up. Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were previously included in another study on the genetic basis of Dupuytren disease. Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is the presence of recurrent Dupuytren disease.


Recruitment information / eligibility

Status Completed
Enrollment 427
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - DD patient - participant in the GODDAF study - genetic data passed the quality control - surgical treatment of DD - written informed consent Exclusion Criteria: - Decisionally incapacitated - Patients treated for DD with collagenase or radiotherapy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands University Medical Center Groningen, dept Plastic Surgery Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence of recurrent Dupuytren disease there is only one measurement in this study 1 day
Secondary Severity of Dupuytren recurrence there is only one measurement in this study 1 day
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