Congenital Hip DislocationGENETHIPNCT02900482
Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France
An observational study of Congenital Hip Dislocation, run by University Hospital, Brest at 1 site in France.
Trial summary
The main objective is to identify the genes involved in congenital dislocation of the hip. The secondary objectives are to measure the association between mechanical risk factors and congenital dislocation of hip and study the interactions between these factors and genetic factors. Read more about this study
- Who is it for?
- Ages 3 weeks to 16 years
- Conditions the study is for
- Congenital Hip Dislocation
- What is being tested?
- Sampling saliva
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2012to 3 Nov 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 3 weeks to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Case group
Who may be able to join
- Old patient at least of 3 weeks and under age 16 presenting a congenital pathology of hip defined by the following consensual criteria:
- Ultrasound criteria: osseous Cover of the femoral head 50 % or Bottom cotyloïdien = 6 mm or Type III and IV of the classification of Graf
- Radiographic criteria: acetabular angle = 30 ° or Absence of projection of the femoral pit in the infero-internal quadrant of the construction of Ombredanne or acetabular angle upper of more than 5 ° with regard to the healthy side (so reached unilateral)
- Patient presenting family history of congenital hip dislocation
- Patient of Caucasian origin
- Signature of the consent
Who cannot join
- Patient presenting anomalies of the collagen and/or the elastic tissue ( imperfect osteogenesis, syndromes of Ehlers-Danlos, Larsen and Marfan)
- Patient presenting karyotype abnormalities
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to identify the genes involved in congenital dislocation of the hip.
The secondary objectives are to measure the association between mechanical risk factors and congenital dislocation of hip and study the interactions between these factors and genetic factors.
Read the detailed description
Congenital hip dislocation (CHD) is one of the most frequent skeleton abnormalities in the Caucasian population (incidence: 2-10 / 1000). This disease results from an abnormality of the reports of the femoral head with the acetabulum, generated by a morphological defect of the cavity and / or joint hypermobility.
This condition is now defined as a multifactorial disease involving in the one hand, mechanical factors related to the conditions of pregnancy and childbirth, and secondly, genetic factors suggested by ethnic predisposition and familial aggregation observed. Despite the neonatal screening, CHD remains a public health problem because of its high frequency, because of the functional handicap which it leads in case of late diagnosis and of its natural evolution to coxarthrosis.
CHD was the object of a significant number of publications on the difficult aspects of its screening and treatment but, at the moment, few data are available on the genetic factors involved.
The genetic studies led on the CHD based on studies of case-control associations, focused on candidate genes, and genetic linkage analysis, two strategies classically used in genetic epidemiology.
To date, these strategies did not allow to elucidate the genetic determinism of the pathology.
The considerable progress made in recent years both in the field of knowledge of the human genome and its variability, in the development of methodological and technological tools allow to better understand the genetic determinism of complex diseases such as CHD.
The development of the techniques of broadband sequencing, new generation said sequencing (NGS for Next Generation Sequencing) makes indeed accessible the sequencing of the whole genome or of the set of its coding regions (exome) and now allows identify rare variants, that is to say variants having a minor allele frequency of less than 1%. These variants were previously not recognizable by the strategies traditionally used in genetic epidemiology, which are based on the study of common variants (minor allele frequency of ≥ 5%) listed in the public databases of the human genome .
The NGS sequencing technique makes it possible to address the problem of the study of complex diseases in a new light and it appears necessary to apply this strategy to the CHD to search for genetic factors involved in the pathology.
The genetic analysis strategy initially envisaged consisted of a genome wide association study (GWAS), which aims to genotype millions of frequent genetic markers scattered along the genome and to test their association with the disease.
The technological advances made in the field of molecular genetics since the implementation of the GENETHIP protocol have made it possible to envisage new strategies to identify the genetic factors involved in a complex disease such as CHD. These strategies include high-throughput sequencing - Next Generation Sequencing (NGS) - which now makes sequencing of all coding regions of the genome (exome) possible. Beyond the frequent variants, this technique also makes it possible to identify rare variants (frequency of the minor allele <1%), not analyzed by the strategy initially envisaged in this project.
It was therefore decided to adopt this new strategy in the GENETHIP study. The sample size could be reduced as the average frequency of the minor allele is lower with this type of study.
The new genetic strategy adopted nevertheless requires the inclusion of selected phenotypes, which leads to recruiting exclusively patients with a family history of congenital hip disorders and excluding those who have had a presentation by the seat (main mechanical risk factor of the CHD). This is intended to better target the genetic character of the pathology.
- Conditions
- Congenital Hip Dislocation
- Being tested
- Sampling saliva
- Medical subject headings
- Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling salivaOther
| Study group | Role | What they receive |
|---|---|---|
| case group | Patients with a history of congenital hip dislocation Receives: Other: Sampling saliva | |
| control group | Patients with no history of congenital hip dislocation Receives: Other: Sampling saliva | |
| parents of case group | Parents of patients with a history of congenital hip dislocation Receives: Other: Sampling saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research for one or several genes involved in the congenital dislocation of hip by comparing the DNA from blood or saliva of patients and controls.
The primary endpoint of the study is to sequence exome of patients affected by congenital dislocation of hip and of controls to identify one or several genes involved in the congenital dislocation of hip and compare the distribution of variants identified by exome sequencing between patients and controls.
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start23 Nov 2012
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Hip DislocationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02900482
- Sponsor's protocol ID
- RB 11.042 GENETHIP
- Acronym
- GENETHIP
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2016
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France
- ClinicalTrials.gov ID
- NCT02900482
- Acronym / sponsor ID
- GENETHIP / RB 11.042 GENETHIP
- Conditions
- Congenital Hip Dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Nov 2012 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 14 Sep 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.
The main objective is to identify the genes involved in congenital dislocation of the hip.
The secondary objectives are to measure the association between mechanical risk factors and congenital dislocation of hip and study the interactions between these factors and genetic factors.
Detailed description
Congenital hip dislocation (CHD) is one of the most frequent skeleton abnormalities in the Caucasian population (incidence: 2-10 / 1000). This disease results from an abnormality of the reports of the femoral head with the acetabulum, generated by a morphological defect of the cavity and / or joint hypermobility.
This condition is now defined as a multifactorial disease involving in the one hand, mechanical factors related to the conditions of pregnancy and childbirth, and secondly, genetic factors suggested by ethnic predisposition and familial aggregation observed. Despite the neonatal screening, CHD remains a public health problem because of its high frequency, because of the functional handicap which it leads in case of late diagnosis and of its natural evolution to coxarthrosis.
CHD was the object of a significant number of publications on the difficult aspects of its screening and treatment but, at the moment, few data are available on the genetic factors involved.
The genetic studies led on the CHD based on studies of case-control associations, focused on candidate genes, and genetic linkage analysis, two strategies classically used in genetic epidemiology.
To date, these strategies did not allow to elucidate the genetic determinism of the pathology.
The considerable progress made in recent years both in the field of knowledge of the human genome and its variability, in the development of methodological and technological tools allow to better understand the genetic determinism of complex diseases such as CHD.
The development of the techniques of broadband sequencing, new generation said sequencing (NGS for Next Generation Sequencing) makes indeed accessible the sequencing of the whole genome or of the set of its coding regions (exome) and now allows identify rare variants, that is to say variants having a minor allele frequency of less than 1%. These variants were previously not recognizable by the strategies traditionally used in genetic epidemiology, which are based on the study of common variants (minor allele frequency of ≥ 5%) listed in the public databases of the human genome .
The NGS sequencing technique makes it possible to address the problem of the study of complex diseases in a new light and it appears necessary to apply this strategy to the CHD to search for genetic factors involved in the pathology.
The genetic analysis strategy initially envisaged consisted of a genome wide association study (GWAS), which aims to genotype millions of frequent genetic markers scattered along the genome and to test their association with the disease.
The technological advances made in the field of molecular genetics since the implementation of the GENETHIP protocol have made it possible to envisage new strategies to identify the genetic factors involved in a complex disease such as CHD. These strategies include high-throughput sequencing - Next Generation Sequencing (NGS) - which now makes sequencing of all coding regions of the genome (exome) possible. Beyond the frequent variants, this technique also makes it possible to identify rare variants (frequency of the minor allele <1%), not analyzed by the strategy initially envisaged in this project.
It was therefore decided to adopt this new strategy in the GENETHIP study. The sample size could be reduced as the average frequency of the minor allele is lower with this type of study.
The new genetic strategy adopted nevertheless requires the inclusion of selected phenotypes, which leads to recruiting exclusively patients with a family history of congenital hip disorders and excluding those who have had a presentation by the seat (main mechanical risk factor of the CHD). This is intended to better target the genetic character of the pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: Sampling salivaPatients with a history of congenital hip dislocation |
| control group | – | Other: Sampling salivaPatients with no history of congenital hip dislocation |
| parents of case group | – | Other: Sampling salivaParents of patients with a history of congenital hip dislocation |
Who may qualify
- Ages
- 3 weeks to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Case group
Key inclusion criteria (6 listed)
- Old patient at least of 3 weeks and under age 16 presenting a congenital pathology of hip defined by the following consensual criteria:
- Patient presenting family history of congenital hip dislocation
- Patient of Caucasian origin
- Signature of the consent
Key exclusion criteria (3 listed)
- Patient presenting anomalies of the collagen and/or the elastic tissue ( imperfect osteogenesis, syndromes of Ehlers-Danlos, Larsen and Marfan)
- Patient presenting karyotype abnormalities
- Refusal to participate
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 |
|---|---|---|
| Sampling saliva | Other | case group, control group, parents of case group |
Primary outcome
Research for one or several genes involved in the congenital dislocation of hip by comparing the DNA from blood or saliva of patients and controls.
Time frame: inclusion
The primary endpoint of the study is to sequence exome of patients affected by congenital dislocation of hip and of controls to identify one or several genes involved in the congenital dislocation of hip and compare the distribution of variants identified by exome sequencing between patients and controls.
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 9 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Congenital Hip Dislocation, run by University Hospital, Brest 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 3 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 9 Feb 2023. 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?
Research for one or several genes involved in the congenital dislocation of hip by comparing the DNA from blood or saliva of patients and controls. (time frame: inclusion). 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 9 Feb 2023.