Conotruncal Cardiac DefectsCCOMETNCT01460316
Conotruncal Cardiac Defects and Nutrigenetic Etiopathogeny
An observational study of Conotruncal Cardiac Defects, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Conotruncal Cardiac Defects
- What is being tested?
- Bood sampling for biochemicals and genetic analysis
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to May 2015
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Conotruncal cardiac defects population and theirs mothers
Who may be able to join
- Conotruncal cardiac defects patients and theirs mothers
- Weight: > 3750 g
Who cannot join
- Syndromic conotruncal cardiac defects
- 22q11 deletion Holder's
- Patients whose mother's took anti-folates before and during first pregnancy semester
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Cardiologie Pédiatrique, CHU Brabois Enfants
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects
The investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.
- Conditions
- Conotruncal Cardiac Defects
- Being tested
- Bood sampling for biochemicals and genetic analysis
- Keywords
- Conotruncal cardiac defects, methylation, genotype, cobalamin, folates, nutrition
- Medical subject headings
- Conotruncal cardiac defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bood sampling for biochemicals and genetic analysisBiological
There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol
| Study group | Role | What they receive |
|---|---|---|
| Conotruncal cardiac defects patients | Not described Receives: Biological: Bood sampling for biochemicals and genetic analysis | |
| Mothers of patients | Not described Receives: Biological: Bood sampling for biochemicals and genetic analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conotruncal Cardiac DefectsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, CHU de Reims
- Responsible party
- Principal investigator, FEILLET François, Central Hospital, Nancy, France
- Investigators
- François FEILLET, MD-PHD, Principal investigator, CHU de Nancy- Hôpital Brabois Enfants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460316
- Sponsor's protocol ID
- 2011-A00346-35
- Acronym
- CCOMET
- Status last verified
- Jan 2016
- First submitted
- 25 Oct 2011
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conotruncal Cardiac Defects and Metabolism, Nutrigenetic Factors of Etiopathogeny of Conotruncal Cardiac Defects
- ClinicalTrials.gov ID
- NCT01460316
- Acronym / sponsor ID
- CCOMET / 2011-A00346-35
- Conditions
- Conotruncal Cardiac Defects
- Keywords
- Conotruncal cardiac defects, methylation, genotype, cobalamin, folates, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon, University Hospital, Strasbourg, France, Centre Hospitalier Universitaire Dijon, CHU de Reims
- Study start
- Oct 2011
- Primary completion
- May 2015 (actual)
- First posted
- 26 Oct 2011 (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 investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conotruncal cardiac defects patients | – | Biological: Bood sampling for biochemicals and genetic analysis |
| Mothers of patients | – | Biological: Bood sampling for biochemicals and genetic analysis |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Conotruncal cardiac defects population and theirs mothers
Key inclusion criteria (2 listed)
- Conotruncal cardiac defects patients and theirs mothers
- Weight: > 3750 g
Key exclusion criteria (3 listed)
- Syndromic conotruncal cardiac defects
- 22q11 deletion Holder's
- Patients whose mother's took anti-folates before and during first pregnancy semester
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 |
|---|---|---|
| Bood sampling for biochemicals and genetic analysisThere will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol | Biological | Conotruncal cardiac defects patients, Mothers of patients |
Primary outcome
Not reported in the source record.
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 27 Jan 2016.
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.
François FEILLET, MD-PHD principal investigator
CHU de Nancy- Hôpital Brabois Enfants
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 Conotruncal Cardiac Defects, run by Central Hospital, Nancy, France 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 2 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 27 Jan 2016. 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.
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 27 Jan 2016.