Is wGRS Associated With DD Recurrence?

Dupuytren Contracture Clinical Trial

Official title:

Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983162
• Other study ID #: 201600670
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Recurrence

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