ClubfootNCT04737083
CGH Array in Bilateral Clubfoot
An observational study of Clubfoot and Prenatal Disorder, run by Central Hospital, Nancy, France.
Trial summary
In prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a CGH-array. We want to study the rate of aberrations in these cases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Clubfoot, Prenatal Disorder
- What is being tested?
- CGH array
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2021to 30 Nov 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women who had their follow-up in our team with a prenatal diagnosis of bilateral clubfoot in their fetus.
Who may be able to join
- pregnant women
- fetus with isolated bilateral clubfoot
Who cannot join
- no
About this study
Official title: Evaluation of CGH Array in Prenatal Diagnosis of Bilateral Clubfoot
In prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a CGH-array. We want to study the rate of aberrations in these cases.
- Conditions
- Clubfoot, Prenatal Disorder
- Being tested
- CGH array
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGH arrayGenetic
a CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening
| Study group | Role | What they receive |
|---|---|---|
| clubfoot fetuses | Not described Receives: Genetic: CGH array |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of abnormal CGH-array in the population
Measured: 9 months
Secondary outcomes (1)
type of abnormalities in CGH-array study
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start31 Jan 2021 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu DAP, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737083
- Sponsor's protocol ID
- 2021PI006
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CGH Array in Prenatal Diagnosis of Bilateral Clubfoot
- ClinicalTrials.gov ID
- NCT04737083
- Acronym / sponsor ID
- 2021PI006
- Conditions
- Clubfoot, Prenatal Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 31 Jan 2021 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 3 Feb 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.
In prenatal diagnosis of isolated bilateral clubfoot our team propose genetic analysis: a CGH-array. We want to study the rate of aberrations in these cases.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clubfoot fetuses | – | Genetic: CGH array |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who had their follow-up in our team with a prenatal diagnosis of bilateral clubfoot in their fetus.
Key inclusion criteria (2 listed)
- pregnant women
- fetus with isolated bilateral clubfoot
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| CGH arraya CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening | Genetic | clubfoot fetuses |
Primary outcome
rate of abnormal CGH-array in the population
Time frame: 9 months
1 secondary outcome
type of abnormalities in CGH-array study
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot and Prenatal Disorder, run by Central Hospital, Nancy, 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 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: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
rate of abnormal CGH-array in the population (time frame: 9 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 3 Feb 2021.