Scoliosis IdiopathicSCOGENNCT05116436
Genetic Study of Idiopathic Scoliosis in a Cohort of Families (SCOGEN)
An observational study of Scoliosis Idiopathic, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This study will focus on a large cohort of multiplex families, to precisely identify candidate genes. The fact of have a large database (fifty families, collected by the principal investigator for more than two decades), will contribute to the discovery of genes of interest. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Blood sample and Spine X-ray
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2020to 6 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Families : patients with idiopathic scoliosis and their relatives
Who may be able to join
- Presence of idiopathic scoliosis, diagnosed by a clinical examination by an orthopedic doctor and confirmed by the presence of a Cobb angle greater than 10 ° on radiographs of the spine
- Signed informed consent
- Affiliation to a social security scheme or beneficiary of such a scheme
- Be related to the first or second degree with at least 2 individuals suffering from idiopathic scoliosis, and whose family tree over 3 generations finds at least 3 cases of idiopathic scoliosis
- Do not present with scoliosis (clinical examination by an orthopedic doctor and x-rays of the spine).
- Affiliation to a social security scheme or beneficiary of such a scheme
Who cannot join
- Non-inclusion criteria for "sick" patients:
- Be part of one of the following categories of vulnerable people: protected adults, adults unable to express their consent and not subject to a protection measure, pregnant women, parturients and nursing mothers, people deprived of their liberty, people hospitalized without consent, people admitted to a health or social establishment for purposes other than research
- Suspicion of scoliosis secondary to clinical examination
- Non-inclusion criteria for "healthy relatives":
- Be part of one of the following categories of vulnerable people: protected adults, adults unable to express their consent and not subject to a protection measure, pregnant women, parturients and nursing mothers, people deprived of their liberty, people hospitalized without consent, people admitted to a health or social establishment for purposes other than research
- Discovery of scoliosis during research (if scoliosis of an idiopathic nature: patient included in the cohort of patients, if secondary scoliosis: exclusion from the family).
- All patients :
- Pregnancy in progress or desired with discontinuation of contraception (contraindication to the realization of x-rays).
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Clinique Maussins-Nollet
Paris, 75019
Jean-François Oudet, 0683346567, jf.oudet@ecten.eu
Marie-Hélène Barba, mh.barba@ecten.eu
About this study
Official title: Genetic Study of Idiopathic Scoliosis in a Cohort of Families
This study will focus on a large cohort of multiplex families, to precisely identify candidate genes. The fact of have a large database (fifty families, collected by the principal investigator for more than two decades), will contribute to the discovery of genes of interest. It will also allow testing for the presence or absence of mutations found in other cohorts in previous studies. The main objective of this study is to identify genetic abnormalities associated with the presence and severity of idiopathic scoliosis, in families of scoliosis.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Blood sample, Spine X-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
It will test the presence or absence of genetic mutations found in other cohorts in previous studies.
Spine X-rayProcedure or surgery
To determine the scoliosis
| Study group | Role | What they receive |
|---|---|---|
| Patient with idiopathic scoliosis | Not described Receives: Procedure: Blood sample; Procedure: Spine X-ray | |
| Healthy related patients | Not described Receives: Procedure: Blood sample; Procedure: Spine X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a mutated allele in scoliosis patients versus their healthy relatives.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start6 Jun 2020
- Primary completion6 Jun 2021
- Study completion6 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Family based
- Time perspective
- Other
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116436
- Sponsor's protocol ID
- 2019-A03136-51
- Acronym
- SCOGEN
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Study of Idiopathic Scoliosis in a Cohort of Families
- ClinicalTrials.gov ID
- NCT05116436
- Acronym / sponsor ID
- SCOGEN / 2019-A03136-51
- Conditions
- Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2022 (estimated)
- First posted
- 11 Nov 2021 (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.
This study will focus on a large cohort of multiplex families, to precisely identify candidate genes. The fact of have a large database (fifty families, collected by the principal investigator for more than two decades), will contribute to the discovery of genes of interest. It will also allow testing for the presence or absence of mutations found in other cohorts in previous studies. The main objective of this study is to identify genetic abnormalities associated with the presence and severity of idiopathic scoliosis, in families of scoliosis.
Study design
- Observational model
- Family based
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with idiopathic scoliosis | – | Procedure: Blood sample, Procedure: Spine X-ray |
| Healthy related patients | – | Procedure: Blood sample, Procedure: Spine X-ray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Families : patients with idiopathic scoliosis and their relatives
Key inclusion criteria (6 listed)
- Presence of idiopathic scoliosis, diagnosed by a clinical examination by an orthopedic doctor and confirmed by the presence of a Cobb angle greater than 10 ° on radiographs of the spine
- Signed informed consent
- Affiliation to a social security scheme or beneficiary of such a scheme
- Be related to the first or second degree with at least 2 individuals suffering from idiopathic scoliosis, and whose family tree over 3 generations finds at least 3 cases of idiopathic scoliosis
- Do not present with scoliosis (clinical examination by an orthopedic doctor and x-rays of the spine).
Key exclusion criteria (8 listed)
- Be part of one of the following categories of vulnerable people: protected adults, adults unable to express their consent and not subject to a protection measure, pregnant women, parturients and nursing mothers, people deprived of their liberty, people hospitalized without consent, people admitted to a health or social establishment for purposes other than research
- Suspicion of scoliosis secondary to clinical examination
- Be part of one of the following categories of vulnerable people: protected adults, adults unable to express their consent and not subject to a protection measure, pregnant women, parturients and nursing mothers, people deprived of their liberty, people hospitalized without consent, people admitted to a health or social establishment for purposes other than research
- Discovery of scoliosis during research (if scoliosis of an idiopathic nature: patient included in the cohort of patients, if secondary scoliosis: exclusion from the family).
- Pregnancy in progress or desired with discontinuation of contraception (contraindication to the realization of x-rays).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleIt will test the presence or absence of genetic mutations found in other cohorts in previous studies. | Procedure or surgery | Healthy related patients, Patient with idiopathic scoliosis |
| Spine X-rayTo determine the scoliosis | Procedure or surgery | Healthy related patients, Patient with idiopathic scoliosis |
Primary outcome
Presence of a mutated allele in scoliosis patients versus their healthy relatives.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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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.
Marie-Hélène Barba contact
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 Scoliosis Idiopathic, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a mutated allele in scoliosis patients versus their healthy relatives. (time frame: 12 months). 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 11 Nov 2021.