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Is wGRS Associated With DD Recurrence?

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ClinicalTrials.gov Identifier: NCT02983162
Recruitment Status : Active, not recruiting
First Posted : December 6, 2016
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
D.C. Broekstra, University Medical Center Groningen

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.


Condition or disease
Dupuytren Contracture

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Study Type : Observational
Estimated Enrollment : 677 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : August 1, 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Presence of recurrent Dupuytren disease [ Time Frame: 1 day ]
    there is only one measurement in this study


Secondary Outcome Measures :
  1. Severity of Dupuytren recurrence [ Time Frame: 1 day ]
    there is only one measurement in this study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983162


Locations
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Netherlands
University Medical Center Groningen, dept Plastic Surgery
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: P. M.N. Werker, MD, PhD University Medical Center Groningen

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Responsible Party: D.C. Broekstra, MSc, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02983162     History of Changes
Other Study ID Numbers: 201600670
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dupuytren Contracture
Contracture
Recurrence
Disease Attributes
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases