Engagement in Participants with Factor V Leiden or Prothrombin G20210A
Research type
Research Study
Full title
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.
IRAS ID
367963
Contact name
Edward Jackson
Contact email
Sponsor organisation
Richmond Research Institute
Duration of Study in the UK
0 years, 10 months, 20 days
Research summary
This study aims to engage people who have, or may have, Factor V Leiden or Prothrombin G20210A, which are genetic changes that can increase the risk of blood clots such as stroke. The study will collect health information to establish a clinical baseline for each participant. This can later help identify which participants are more likely to be included in Factor V Leiden or Prothrombin G20210A-related clinical trials.
The study also helps participants understand what taking part in a clinical trial involves. It gives them the chance to visit the clinical trials unit and become familiar with the clinical team before deciding whether they would like to join future studies related to these conditions.
Targeted genetic testing will be used to confirm whether participants have Factor V Leiden or Prothrombin G20210A. This is particularly helpful for people from groups where these genetic changes are suspected and may allow some participants to receive a formal diagnosis.
The study will take approximately 10 weeks for participants to complete, consisting of 1 to 2 visits and a follow-up telephone call. Participants will first attend a screening visit, where the study will be explained and written consent will be taken. Following the informed consent, a genetic test will be performed for participants who are suspected of having Factor V Leiden or Prothrombin G20210A mutations
Participants with confirmed diagnosis will be invited to a Day 1 visit. At this visit, participants will undergo a series of basic clinical assessments, such as blood pressure, heart recordings (ECGs), and blood tests. These assessments will help to establish a clinical baseline of the participant’s health. Participants will receive a guided tour of the clinical trial unit to become familiar with its setting and environment.
Participants may also be provided with a hard copy of a Participant Information Sheet/Informed Consent Form (PIS/ICF) of any future relevant clinical trial (provided this document has received approval from the REC). This will allow potential participants to take the information home for a thorough review and discussion with friends and family before potentially attending a screening appointment for any future trials. A follow-up telephone call with the Study Doctor will be conducted within 1 week after Day 1 to discuss the results of the clinical assessments, allow participants to ask any questions and arrange specialist referrals or follow-up from their GP if required to support the participant's ongoing care
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
26/WM/0035
Date of REC Opinion
17 Feb 2026
REC opinion
Further Information Favourable Opinion