Genetic of SportS Induced Endofibrotic Remodeling | NCT02704260

Studies
Genetic of SportS Induced Endofibrotic Remodeling

NCT02704260

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Nov 1, 2017Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Genetic Syndrome

Interventions

GENETIC ANALYSIS

Countries

France

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2016Actual

Primary Completion Date

Sep 2, 2016Actual

Completion Date

Sep 2, 2016Actual

First Submitted Date

Feb 23, 2016

First Submission Date that Met QC Criteria

Mar 4, 2016

First Posted Date

Mar 9, 2016Estimated

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

Oct 30, 2017

Last Update Posted Date

Nov 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

search for a genetic cause of vascular endofibrose

Detailed Description

Perform a DNA analysis to mark the existence of mutations in one or more genes encoding proteins involved in vascular remodeling high.

5 patients or relatives of patients topics

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GENETIC ANALISYS	Experimental	GENETIC ANALYSIS AND RESEARCH OF GENETIC BLOOD SAMPLE	Genetic: GENETIC ANALYSIS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GENETIC ANALYSIS	Genetic	prélevement blood to search for a genetic cause of vascular endofibrose. Search genetic mutations in 5 subjects.	GENETIC ANALISYS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of mutations or nucleotides variations	DNA analysis and search for genetic mutations	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

High level reached Cyclists vascular endofibrose
Cyclist high level and not sick with a brother or sister is senior cyclist reaches the vascular endofibrose.

Exclusion Criteria:

not obtaining consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
PIERRE ABRAHAM, PROFESSOR	UH ANGERS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Angers		49933	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D030342	Genetic Diseases, Inborn

Ancestor Terms

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided