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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

Tracking Information
First Submitted Date December 2, 2016
First Posted Date December 6, 2016
Last Update Posted Date February 22, 2019
Actual Study Start Date March 10, 2017
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 5, 2016)
Presence of recurrent Dupuytren disease [ Time Frame: 1 day ]
there is only one measurement in this study
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02983162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 5, 2016)
Severity of Dupuytren recurrence [ Time Frame: 1 day ]
there is only one measurement in this study
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is wGRS Associated With DD Recurrence?
Official Title Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Dupuytren Contracture
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 5, 2016)
677
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2020
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT02983162
Other Study ID Numbers 201600670
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party D.C. Broekstra, University Medical Center Groningen
Study Sponsor University Medical Center Groningen
Collaborators Not Provided
Investigators
Principal Investigator: P. M.N. Werker, MD, PhD University Medical Center Groningen
PRS Account University Medical Center Groningen
Verification Date February 2019