Early OsteoarthritisNCT04267510
Clinical and Molecular Aspects of Early Osteoarthritis
An observational study of Early Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The etiology of osteoarthritis is varied, ranging from multifactorial, environmental to monogenic. In individuals in whom osteoarthritis appears earlier than in the general population, it is called early osteoarthritis. To our knowledge, there are no large-scale genetic studies on people with early osteoarthritis. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Early Osteoarthritis
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2013to 1 Jan 2020
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with early osteoarthritis who have undergone genetic sequencing
Who may be able to join
- Patients with early osteoarthritis who have undergone genetic sequencing
Who cannot join
- Patients refusing to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
The etiology of osteoarthritis is varied, ranging from multifactorial, environmental to monogenic. In individuals in whom osteoarthritis appears earlier than in the general population, it is called early osteoarthritis. To our knowledge, there are no large-scale genetic studies on people with early osteoarthritis. The investigators therefore sought to study the causes of monogenic osteoarthritis in people suffering from early non-syndromic osteoarthritis.
Material and method From 2013 to 2019, experts in constitutional bone disease sent patients with non-syndromic early osteoarthritis for genetic analysis to our center of competence for constitutional bone diseases. The sequencing of a panel of genes was carried out by NGS.
- Conditions
- Early Osteoarthritis
- Keywords
- genetic sequencing
- Medical subject headings
- Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
identification of genetic mutation
sequencing out by NGS
Measured: 1 day
number of genetic mutation
sequencing out by NGS
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 posted13 Feb 2020
- Study start1 Jan 2013
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David GENEVIEVE, Principal investigator, Department of Medical Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267510
- Sponsor's protocol ID
- RECHMPL20_0085
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Aspects of Early Osteoarthritis
- ClinicalTrials.gov ID
- NCT04267510
- Acronym / sponsor ID
- RECHMPL20_0085
- Conditions
- Early Osteoarthritis
- Keywords
- genetic sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 13 Feb 2020 (actual)
- 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.
The etiology of osteoarthritis is varied, ranging from multifactorial, environmental to monogenic. In individuals in whom osteoarthritis appears earlier than in the general population, it is called early osteoarthritis. To our knowledge, there are no large-scale genetic studies on people with early osteoarthritis. The investigators therefore sought to study the causes of monogenic osteoarthritis in people suffering from early non-syndromic osteoarthritis.
Material and method From 2013 to 2019, experts in constitutional bone disease sent patients with non-syndromic early osteoarthritis for genetic analysis to our center of competence for constitutional bone diseases. The sequencing of a panel of genes was carried out by NGS.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with early osteoarthritis who have undergone genetic sequencing
Key inclusion criteria (1 listed)
- Patients with early osteoarthritis who have undergone genetic sequencing
Key exclusion criteria (1 listed)
- Patients refusing to participate in research
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
identification of genetic mutation
Time frame: 1 day
sequencing out by NGS
number of genetic mutation
Time frame: 1 day
sequencing out by NGS
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 13 Feb 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
David GENEVIEVE principal investigator
Department of Medical Genetics
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 Early Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 1 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 13 Feb 2020. 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 France. 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?
identification of genetic mutation (time frame: 1 day). The study lists 2 primary outcomes in all. 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 13 Feb 2020.