Dupuytren ContractureNCT02983162
Is wGRS Associated With DD Recurrence?
An observational study of Dupuytren Contracture, run by University Medical Center Groningen at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Contracture
- How many people
- 427 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Mar 2017to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- DD patient
- participant in the GODDAF study
- genetic data passed the quality control
- surgical treatment of DD
- written informed consent
Who cannot join
- Decisionally incapacitated
- Patients treated for DD with collagenase or radiotherapy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen, dept Plastic Surgery
Groningen, 9700 RB
About this study
Official title: Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?
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.
Read more
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
- Medical subject headings
- Dupuytren Contracture
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of recurrent Dupuytren disease
there is only one measurement in this study
Measured: 1 day
Secondary outcomes (1)
Severity of Dupuytren recurrence
there is only one measurement in this study
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start10 Mar 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren ContractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.C. Broekstra, University Medical Center Groningen
- Investigators
- P. MN Werker, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983162
- Sponsor's protocol ID
- 201600670
- Status last verified
- Feb 2022
- First submitted
- 2 Dec 2016
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?
- ClinicalTrials.gov ID
- NCT02983162
- Acronym / sponsor ID
- 201600670
- Conditions
- Dupuytren Contracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- DD patient
- participant in the GODDAF study
- genetic data passed the quality control
- surgical treatment of DD
- written informed consent
Key exclusion criteria (2 listed)
- Decisionally incapacitated
- Patients treated for DD with collagenase or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of recurrent Dupuytren disease
Time frame: 1 day
there is only one measurement in this study
1 secondary outcome
Severity of Dupuytren recurrence
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P. MN Werker, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dupuytren Contracture, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of recurrent Dupuytren disease (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.