Characterisation of biomarkers in patients with vascular malformations
Research type
Research Study
Full title
Identification and characterisation of clinical, imaging and molecular biomarkers to predict outcomes in patients with vascular malformations
IRAS ID
243792
Contact name
Chung Sim Lim
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Clinicaltrials.gov Identifier
0000, 0000
Duration of Study in the UK
4 years, 11 months, 29 days
Research summary
Vascular malformations are abnormally developed clusters of blood vessels consisting of arteries, veins, lymphatics, capillaries or a combination of them, that could affect any part of the body. Patients with vascular malformations may suffer from pain, bleeding, body disfiguring, decreased function, overgrowth, organ failure and major limb amputation. The treatment options for patients with vascular malformations include supportive measures (e.g. support garments and pain killers), embolo-sclerotherapy (injection of substances into the vascular malformations to occlude them), and surgery. Unfortunately, patient response or outcome following these therapies is often uncertain, making informed consent and treatment planning challenging for both patient and clinician. Therefore, the aim of the study is to identify potential clinical, imaging (scans) and molecular biomarkers that may help to predict treatment (or no treatment) outcomes, and individualise treatment strategy for patients with vascular malformations. This will be a prospective observational study using routinely collected longitudinal clinical data, imaging and biological samples for analysis of biomarkers without altering the standard treatment pathway of patients. They include (I) clinical biomarkers including outcome measures from clinical assessment, and validated symptoms scoring and quality of life questionnaires; (II) molecular biomarkers from blood, urine and tissue biopsy samples; (III) imaging biomarkers including data from ultrasound Doppler, computed tomography, magnetic resonance, and blood flow and pressure measurements. All adult patients with vascular malformations cared by the Royal Free London Vascular Malformation Service will be considered for the study. Patient recruitment, clinical and imaging data, and biological specimens will be collected at the Royal Free London NHS Foundation Trust sites. The laboratory work and data analysis will be conducted in both Royal Free London NHS Foundation Trust and University College London (UCL) sites. The study will be expected to last for 5 years and to allow sufficient follow-up duration to assess meaningful clinical outcomes.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0090
Date of REC Opinion
6 Feb 2019
REC opinion
Favourable Opinion