PROCEED-UC v2.0
Research type
Research Study
Full title
Prognostic value of Red Density in Ulcerative Colitis
IRAS ID
276046
Contact name
Uday Shivaji
Contact email
Sponsor organisation
UZ Leuven
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Ulcerative Colitis (UC) is a chronic, relapsing disease. Patients are monitored but the assessment of disease activity is challenging. Current endoscopic tools are all based on the subjective assessment of the observer. There is some indication that better outcomes can be achieved where complete endoscopic remission is observed compared to endoscopic improvement alone. Therefore, a more objective assessment of disease activity is required.
Red Density (RD) is an objective real time digital endoscopic tool. It is integrated in a prototype endoscope which includes a processor, and extracts pixel data from high definition white light endoscopic images to provide an endoscopic score displayed as a colour map.
RD has been shown to correlate with UCEIS and MES scores and to detect changes in disease activity following initiation of therapy.
Therefore, the PROCEED-UC study aims to further validate the clinical predictive value of the RD score for sustained clinical and endoscopic remission.
In the UK, patients with UC which is currently in remission, will be recruited from two centres. Study procedures will be carried out as part of standard care for patients with UC, and it is not anticipated that further hospital visits will be required.
Patients will undergo endoscopy at baseline using the RD scope. Patients will then be followed up for 52 weeks or until clinical relapse occurs. A routine clinic visit, will occur at week 26 and a further endoscopy will be done at week 52. Interim follow ups at week 13 and 39 will be done by review of notes and telephone contact with patient. Standard care samples will be taken: biopsies at endoscopy visits, and blood and stool samples at all timepoints.
The primary endpoint is the number of patients with sustained clinical remission.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0111
Date of REC Opinion
19 May 2020
REC opinion
Further Information Favourable Opinion