PROFILE - personalised medicine in Crohn's disease
Research type
Research Study
Full title
PRedicting Outcomes For Crohn’s dIsease using a moLecular biomarkEr (PROFILE) trial
IRAS ID
220851
Contact name
Miles Parkes
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eudract number
2017-000101-20
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study aims to demonstrate that a new 'biomarker' test will allow patients with Crohn's disease to the receive the most appropriate treatment from the time of diagnosis.
Crohn's disease is a chronic, debilitating intestinal condition, which typically occurs in young adults.
Once a patient is diagnosed, there is no way to predict how the disease will behave over their lifetime. Some patients may have frequent flare-ups and require treatment that involves hospital admission, toxic drugs and even surgery to remove severely damaged intestine, whereas others may have very few problems. Ideally, patients would receive treatment that is the most appropriate for them from diagnosis - using the most aggressive therapies for patients destined to experience aggressive disease, while avoiding drug toxicity and healthcare costs in those destined for mild disease. Unfortunately such "personalised therapy" will not be possible until doctors can reliably predict how an individual's disease will behave in the future.
We have developed and validated a specialised 'biomarker' test, which by measuring expression of specific genes in a blood sample, can identify those patients who will experience aggressive disease and those who will experience much milder disease. The PROFILE trial aims to test whether this biomarker can deliver personalised medicine and improve outcomes in patients newly diagnosed with Crohn's disease.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0382
Date of REC Opinion
2 Nov 2017
REC opinion
Further Information Favourable Opinion