Is wGRS Associated With DD Recurrence?

NCT02983162 | Completed

• 1 other identifier: 201600670
• Study Type: observational
• Target: 427
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dupuytren Contracture

Outcome Measures

Primary Outcomes (1)

• Presence of recurrent Dupuytren disease

  there is only one measurement in this study

  1 day

Secondary Outcomes (1)

• Severity of Dupuytren recurrence

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are selected among those who participated in a previous study on the genetic basis of Dupuytren disease (GODDAF). In this study, patients with Dupuytren disease, Peyronie disease or Ledderhose disease and their family members were included. To answer the current research question, only the DD patients are required. The GODDAF study was a multi-center study. For practical reasons, we only want to include patients who were admitted to the UMCG. 1098 participants were included in the GODDAF study in the Netherlands. Of them 797 were DD patients. Of these 797 patients, we estimate that approximately 85% (677) were admitted to the UMCG. These patients will be approached for participation.

You may qualify if:

• DD patient
• participant in the GODDAF study
• genetic data passed the quality control
• surgical treatment of DD
• written informed consent

You may not qualify if:

• Decisionally incapacitated
• Patients treated for DD with collagenase or radiotherapy

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen, dept Plastic Surgery

Groningen, 9700 RB, Netherlands

Location

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• P. MN Werker, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: March 10, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)