InjuriesNCT04952662
Candidate Gene Association Study With Injury in Elite Male Youth Football Players
An observational study of Injuries and Genetic Change, run by St Mary's University College at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Injuries, Genetic Change
- What is being tested?
- Genetic variants
- How many people
- 123 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Dec 2019to 31 May 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 8 to 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Elite male youth football players
Who may be able to join
- Elite Male Footballer Player Registered at Fulham Football Club
Who cannot join
- Female no longer registered at Fulham Football Club
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Fulham Football Club
London, New Malden, KT3 6PT
St Mary's University, Twickenham
London, Twickenham, TW1 4SX
About this study
Official title: Candidate Gene Association Study With Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury in Elite Male Youth Football Players
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.
Read the 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.
- Conditions
- Injuries, Genetic Change
- Being tested
- Genetic variants
- Keywords
- SNP, Apophysitis, Fracture, Strain, Sprain, Genetic, Injury
- Medical subject headings
- Wounds and Injuries, Fractures, Bone, Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic variantsGenetic
COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of non-injured and injured participants with injury risk alleles
Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Dec 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjuriesStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's University College
- Sponsor type
- University, hospital or other
- Collaborators
- Fulham Football Club
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952662
- Sponsor's protocol ID
- SMEC_2019-20_002
- Status last verified
- Jul 2021
- First submitted
- 31 May 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candidate Gene Association Study With Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury in Elite Male Youth Football Players
- ClinicalTrials.gov ID
- NCT04952662
- Acronym / sponsor ID
- SMEC_2019-20_002
- Conditions
- Injuries, Genetic Change
- Keywords
- SNP, Apophysitis, Fracture, Strain, Sprain, Genetic, Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- St Mary's University CollegeUniversity, hospital or other
- Collaborators
- Fulham Football Club
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 7 Jul 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 8 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Elite male youth football players
Key inclusion criteria (1 listed)
- Elite Male Footballer Player Registered at Fulham Football Club
Key exclusion criteria (1 listed)
- Female no longer registered at Fulham Football Club
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 |
|---|---|---|
| Genetic variantsCOL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383 | Genetic | – |
Primary outcome
Number of non-injured and injured participants with injury risk alleles
Time frame: 8 Years
Injury, Non-Contact Injury, Non-Contact Muscle Injury, Fracture and Apophysitis Injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Injuries and Genetic Change, run by St Mary's University College at 2 sites in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of non-injured and injured participants with injury risk alleles (time frame: 8 Years). 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 7 Jul 2021.