NCT04952662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

May 31, 2021

Last Update Submit

July 6, 2021

Conditions

Keywords

SNPApophysitisFractureStrainSprainGeneticInjury

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383

Eligibility Criteria

Age8 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Elite male youth football players

You may qualify if:

  • Elite Male Footballer Player Registered at Fulham Football Club

You may not qualify if:

  • Female no longer registered at Fulham Football Club

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fulham Football Club

London, New Malden, KT3 6PT, United Kingdom

Location

St Mary's University, Twickenham

London, Twickenham, TW1 4SX, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Wounds and InjuriesFractures, BoneSprains and Strains

Interventions

Pharmacogenomic Variants

Intervention Hierarchy (Ancestors)

Polymorphism, GeneticGenetic VariationGenetic Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2021

First Posted

July 7, 2021

Study Start

December 1, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations