Varicose VeinsNCT02870127
Clinical Investigation and Molecular Forms of Family Disease of Varicose
An observational study of Varicose Veins, run by Nantes University Hospital at 2 sites in France.
Trial summary
The existence of a family factor in the genesis of varicose veins is certain, but few studies have addressed reliably instead of the genetic factor in clinical and molecular level. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- blood sample
- How many people
- 430 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2013to 19 Dec 2016
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The initial step of this protocol relies on recruiting large families (> 8 met) for a genetic linkage analysis. It consists firstly in identifying patients with varicose veins occurring in a family context, and to conduct a comprehensive survey to assess the potentially informative family (significant number of individuals with multiple generations) and ensure their membership prior to the study. The next step is the fine and accurate phenotyping of each of the family members and the collection of a blood sample for DNA extraction for molecular genetic analysis (family linkage analysis and sequencing exome ).
Who may be able to join
- Any patient consultant the Medicine Vascular Surgery for varicose veins of the lower limbs as part of a manifesto family context
- Varices Presence in at least one family member
- Written consent
Who cannot join
- Patients who are unable to sign or who refuse to sign an informed consent
- Subjects aged less than 25 years, due to the low penetrance of varicose disease that age.
- Secondary veins at a post-thrombotic disease (suspected by the examination and confirmed by Doppler ultrasonography of the deep venous system)
- Venous angiodysplasia or secondary varicose arteriovenous fistulas.
Trial locations and contacts
2 sites in 1 country.
France2 sites
La Roche sur Yon Hospital
La Roche-sur-Yon, 85000
Nantes Univesrity Hospital
Nantes, 44093
About this study
Official title: Genetic Study of Varicose Disease by Sequencing Exome
The existence of a family factor in the genesis of varicose veins is certain, but few studies have addressed reliably instead of the genetic factor in clinical and molecular level. The investigator initiated an original study to identify one or more genetic abnormalities predisposing to varicose disease, based on a combined approach of genetic linkage and of exome sequencing. The clinical research phase is an essential prerequisite to the identification of genetic mutations; it is to identify large affected families and ensure an extremely rigorous and accurate phenotyping of individuals over several generations. A first clinical work has identified and / or phenotype 8 families with a genetically informative family suggesting autosomal dominant inheritance. Linkage analysis suggested several candidate chromosomal regions without allowing the identification of a gene. This project aims to resume and expand the Family clinical investigations and apply the techniques of genome analysis points, including exome sequencing on the most informative families to identify the genes and mechanisms responsible of this disease and improve the prevention and the treatment of varicose veins.
- Conditions
- Varicose Veins
- Being tested
- blood sample
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic abnormalities segregating with the presence of varicose veins in the informative families recruited.
Measured: year 4
Secondary outcomes (1)
genotype/phenotype relationship
improving knowledge of the genotype / phenotype based on genes identified in different families.
Measured: year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start1 Jun 2013
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Marc-Antoine Pistorius, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870127
- Sponsor's protocol ID
- RC12_0142
- Status last verified
- Apr 2019
- First submitted
- 12 Aug 2016
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Study of Varicose Disease by Sequencing Exome
- ClinicalTrials.gov ID
- NCT02870127
- Acronym / sponsor ID
- RC12_0142
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 17 Aug 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 existence of a family factor in the genesis of varicose veins is certain, but few studies have addressed reliably instead of the genetic factor in clinical and molecular level. The investigator initiated an original study to identify one or more genetic abnormalities predisposing to varicose disease, based on a combined approach of genetic linkage and of exome sequencing. The clinical research phase is an essential prerequisite to the identification of genetic mutations; it is to identify large affected families and ensure an extremely rigorous and accurate phenotyping of individuals over several generations. A first clinical work has identified and / or phenotype 8 families with a genetically informative family suggesting autosomal dominant inheritance. Linkage analysis suggested several candidate chromosomal regions without allowing the identification of a gene. This project aims to resume and expand the Family clinical investigations and apply the techniques of genome analysis points, including exome sequencing on the most informative families to identify the genes and mechanisms responsible of this disease and improve the prevention and the treatment of varicose veins.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The initial step of this protocol relies on recruiting large families (> 8 met) for a genetic linkage analysis. It consists firstly in identifying patients with varicose veins occurring in a family context, and to conduct a comprehensive survey to assess the potentially informative family (significant number of individuals with multiple generations) and ensure their membership prior to the study. The next step is the fine and accurate phenotyping of each of the family members and the collection of a blood sample for DNA extraction for molecular genetic analysis (family linkage analysis and sequencing exome ).
Key inclusion criteria (3 listed)
- Any patient consultant the Medicine Vascular Surgery for varicose veins of the lower limbs as part of a manifesto family context
- Varices Presence in at least one family member
- Written consent
Key exclusion criteria (4 listed)
- Patients who are unable to sign or who refuse to sign an informed consent
- Subjects aged less than 25 years, due to the low penetrance of varicose disease that age.
- Secondary veins at a post-thrombotic disease (suspected by the examination and confirmed by Doppler ultrasonography of the deep venous system)
- Venous angiodysplasia or secondary varicose arteriovenous fistulas.
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 sample | Other | – |
Primary outcome
genetic abnormalities segregating with the presence of varicose veins in the informative families recruited.
Time frame: year 4
1 secondary outcome
genotype/phenotype relationship
Time frame: year 4
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 24 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Marc-Antoine Pistorius, PU-PH principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by Nantes University Hospital at 2 sites 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 3 inclusion and 4 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
genetic abnormalities segregating with the presence of varicose veins in the informative families recruited. (time frame: year 4). 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 24 Apr 2019.