Candidate Gene Association Study With Injury in Elite Mal... | NCT04952662

Studies
Candidate Gene Association Study With Injury in Elite Male Youth Football Players

NCT04952662

Sponsor

St Mary's University College

Status

Completed

Last Update Posted

Jul 7, 2021Actual

Enrollment

123Actual

Phase

Not provided

Conditions

Injuries
Genetic Change

Interventions

Genetic variants

Countries

United Kingdom

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

Jul 2021

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

Dec 1, 2019Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

May 31, 2021Actual

First Submitted Date

May 31, 2021

First Submission Date that Met QC Criteria

Jul 6, 2021

First Posted Date

Jul 7, 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

Jul 6, 2021

Last Update Posted Date

Jul 7, 2021Actual

Name	Class
Fulham Football Club	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

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

Understanding how candidate genes, previously associated with injury susceptibility, influence the incidence of muscle, bone, ligament, and tendon injuries across the development pathway of elite footballers may provide valuable insight into inherent injury predisposition to support the long-term development of every individual. Therefore, the aim of the present study was to investigate the association between candidate genetic variants and muscle, bone, ligament, and tendon injuries in elite football with sub-analysis of the influence of age and maturation on injury susceptibility.

Detailed Description

Genetic variants in several candidate genes which code for structural constituents (COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722 and ACTN3 rs1815739), regulatory components (ACE rs1799752, ESR1 rs2234693 and MMP3 rs679620) and transcription factors (VDR rs2228570 and GDF5 rs143383) affecting the form, function and injury susceptibility of muscle, bone, ligament, and tendon tissue will be associated with overall injury, non-contact, bone, ligament, tendon and apophysitis injury risk in elite male youth and adult footballers.

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

Retention

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genetic variants	Genetic	COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of non-injured and injured participants with injury risk alleles	Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury	8 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elite Male Footballer Player Registered at Fulham Football Club

Exclusion Criteria:

Female no longer registered at Fulham Football Club

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Elite male youth football players

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fulham Football Club		London	New Malden	KT3 6PT	United Kingdom
St Mary's University, Twickenham

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D050723	Fractures, Bone
D013180	Sprains and Strains

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000071184	Pharmacogenomic Variants

Ancestor Terms

ID	Term
D011110	Polymorphism, Genetic
D014644	Genetic Variation
D055614	Genetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided