Impact of double heterozygosity for Factor V Leiden and Prothrombin G20210A on the thrombotic phenotype.
Beate Luxembourg, Franziska Henke, Anette Kirsch-Altena...
https://pubmed.ncbi.nlm.nih.gov/33588106Actively Recruiting
Age: 18Years +
All Genders
ID07584265
Engagement Study to Establish a Clinical Baseline for Adult Participants With Factor V Leiden or Prothrombin G20210A Mutation and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation
Led by Richmond Research Institute · Updated on 2026-05-29
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are enrolling adults who have or may have Factor V Leiden or Prothrombin G20210A mutations, which are genetic changes linked to a higher risk of blood clots like stroke. The study aims to establish a health baseline for each participant and help identify who might be eligible for future clinical trials related to these genetic conditions. It also helps participants learn about clinical research and become comfortable with the clinical trial environment. Participants suspected of having these mutations will undergo targeted genetic testing to confirm their status. Those confirmed will attend a Day 1 visit for basic health checks including blood pressure measurement, ECG, and blood tests to assess overall health. They will also be given a guided tour of the clinical trial unit and may receive information about future related trials. The study spans about 10 weeks, involving 1 to 2 visits and a follow-up phone call. During participation, consent will be obtained and genetic testing performed if needed. After the Day 1 visit, a follow-up call with the study doctor will review health results, answer questions, and arrange any necessary referrals. The main measure is participants' willingness to be contacted for future trials. Secondary measures include genetics, blood clot history, medications, vital signs, lab tests, and ECG. The study supports ongoing care and familiarizes participants with clinical research procedures.
CONDITIONS
Brief Title
Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at the time of consent
- Ability to provide written, personally signed, and dated informed consent
- Confirmed or suspected diagnosis of Factor V Leiden or Prothrombin G20210A mutation via targeted genetic testing
You will not qualify if you...
- Unwilling or unable to comply with the protocol-defined study assessments
- Any other significant disease or disorder that may place the participant at risk or affect the clinical baseline, as judged by the Principal Investigator or Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo targeted genetic testing to confirm the presence of Factor V Leiden or Prothrombin G20210A mutations and establish a clinical baseline through basic clinical assessments, including blood pressure, ECG, and blood tests, and receive a guided tour of the clinical trials unit.
1 in-person visit (Day 1)
Long-term Monitoring
Duration - Within 1 week after Day 1
Participants receive a follow-up telephone call within one week after the Day 1 visit to discuss assessment results, ask questions, and arrange any necessary referrals or follow-up care.
1 telephone call
Trial Site Locations
Total: 1 location
1
Richmond Pharmacology Limited
London, United Kingdom, SE1 1YR
Actively Recruiting
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Research Team
J
James Rickard, MPharm
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Social aspects of genetic testing for factor V Leiden mutation in healthy individuals and their importance for daily practice.
Ivan Bank, Michael P R B Scavenius, Harry R Büller...
https://pubmed.ncbi.nlm.nih.gov/15081560High risk of thrombosis recurrence in patients with homozygous and compound heterozygous factor V R506Q (Factor V Leiden) and prothrombin G20210A.
Elizabeth H Federici, Hamid Al-Mondhiry
https://pubmed.ncbi.nlm.nih.gov/31472339