CGH Array in Bilateral Clubfoot | NCT04737083

Studies
CGH Array in Bilateral Clubfoot

NCT04737083

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Feb 3, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Clubfoot
Prenatal Disorder

Interventions

CGH array

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2021Estimated

Primary Completion Date

Feb 15, 2021Estimated

Completion Date

Nov 30, 2021Estimated

First Submitted Date

Jan 25, 2021

First Submission Date that Met QC Criteria

Jan 31, 2021

First Posted Date

Feb 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2021

Last Update Posted Date

Feb 3, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthieu DAP, medical doctor (MD), Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clubfoot fetuses			Genetic: CGH array

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CGH array	Genetic	a CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening	clubfoot fetuses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of abnormal CGH-array in the population		9 months

Secondary Outcomes

Measure	Description	Time Frame
type of abnormalities in CGH-array study		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pregnant women
fetus with isolated bilateral clubfoot

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant women who had their follow-up in our team with a prenatal diagnosis of bilateral clubfoot in their fetus.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003025	Clubfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided