<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02983162</url>
  </required_header>
  <id_info>
    <org_study_id>201600670</org_study_id>
    <nct_id>NCT02983162</nct_id>
  </id_info>
  <brief_title>Is wGRS Associated With DD Recurrence?</brief_title>
  <official_title>Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a&#xD;
      significant association between the weighted genetic risk score and Dupuytren disease&#xD;
      recurrence. However, a significant dose-response relation was not found. This might be caused&#xD;
      by underestimating the recurrence rate, due to the retrospective nature of determining&#xD;
      recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to&#xD;
      see whether they suffered from recurrent disease.&#xD;
&#xD;
      Objective: We aim to determine whether the wGRS is associated with recurrent DD.&#xD;
&#xD;
      Study design: An observational study, in which the participants of the GODDAF study are&#xD;
      followed up.&#xD;
&#xD;
      Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were&#xD;
      previously included in another study on the genetic basis of Dupuytren disease.&#xD;
&#xD;
      Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is&#xD;
      the presence of recurrent Dupuytren disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of recurrent Dupuytren disease</measure>
    <time_frame>1 day</time_frame>
    <description>there is only one measurement in this study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of Dupuytren recurrence</measure>
    <time_frame>1 day</time_frame>
    <description>there is only one measurement in this study</description>
  </secondary_outcome>
  <enrollment type="Actual">427</enrollment>
  <condition>Dupuytren Contracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants are selected among those who participated in a previous study on the genetic&#xD;
        basis of Dupuytren disease (GODDAF). In this study, patients with Dupuytren disease,&#xD;
        Peyronie disease or Ledderhose disease and their family members were included. To answer&#xD;
        the current research question, only the DD patients are required. The GODDAF study was a&#xD;
        multi-center study. For practical reasons, we only want to include patients who were&#xD;
        admitted to the UMCG.&#xD;
&#xD;
        1098 participants were included in the GODDAF study in the Netherlands. Of them 797 were DD&#xD;
        patients. Of these 797 patients, we estimate that approximately 85% (677) were admitted to&#xD;
        the UMCG. These patients will be approached for participation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  DD patient&#xD;
&#xD;
          -  participant in the GODDAF study&#xD;
&#xD;
          -  genetic data passed the quality control&#xD;
&#xD;
          -  surgical treatment of DD&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decisionally incapacitated&#xD;
&#xD;
          -  Patients treated for DD with collagenase or radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>P. MN Werker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Groningen, dept Plastic Surgery</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>D.C. Broekstra</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dupuytren Contracture</mesh_term>
    <mesh_term>Contracture</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02983162
org study id: 201600670
nct id: NCT02983162
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Presence of recurrent Dupuytren disease
time frame: 1 day
description: there is only one measurement in this study
measure: Severity of Dupuytren recurrence
time frame: 1 day
description: there is only one measurement in this study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: P. MN Werker, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: D.C. Broekstra
investigator title: MSc
mesh term: Dupuytren Contracture
mesh term: Contracture
mesh term: Recurrence
sharing ipd: No