NCT07430540

Optimising Colorectal Cancer Patient Pathways

Not yet recruiting NA Last updated 24 February 2026

What this trial tests

NA trial testing Additional FIT testing in Colorectal Cancer in 1,000 participants. Not yet recruiting.

Timeline

23 March 2026

Primary endpoint
22 March 2028

22 March 2037

Quick facts

Lead sponsor	University of Edinburgh
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1,000
Start date	23 March 2026
Primary completion	22 March 2028
Estimated completion	22 March 2037
Sites	1 location across United Kingdom

Drugs / interventions tested

• Additional FIT testing

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Significant Bowel Pathology — all drugs for Significant Bowel Pathology →

Sponsor

University of Edinburgh

Who can join

18 and older, any sex, with Colorectal Cancer or Significant Bowel Pathology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bowel cancer (colorectal cancer) is the 4th most common cancer in Scotland. Approximately 4,000 cases are diagnosed annually. Cancer-related deaths in Scotland are higher than other UK nations. Improving the early detection of bowel cancer, and therefore survival, is important.

The majority of bowel cancers are diagnosed within secondary-care (colorectal surgery unit). Upon GP referral to secondary-care, patients provide stool samples which are analysed for microscopic blood (FIT; faecal immunohistochemical test). Patients with a single positive result are more likely to have bowel cancer (0.2% risk if no blood detected, but 8.4% if detected). A positive test triggers further investigation, either CT scan or colonoscopy depending on the result. Currently, colonoscopy and radiology services throughout Scotland are under significant pressure causing delays.

Only 2% of patients referred to secondary-care are diagnosed with bowel cancer, and most colonoscopies performed do not yield significant findings. We have shown that performing two repeated FITs upon referral improves cancer pick-up rate (sensitivity) and reduces missed cancers. We successfully implemented this in NHS Lothian and contributed to national guidelines. Optimising allocation of investigations and therefore improving the detection-rate (specificity) may reduce colonoscopy demand, saving vital resources.

NHS Lothian patients referred to secondary-care with symptoms concerning of bowel cancer will be included. \~1,000 included patients will undertake extra FIT tests in study whether changes in stool blood levels over time help better allocate investigations and improve test specificity. With these results, a new secondary-care pathway will be designed. Health economic analysis will determine costs and benefits of implementing a new pathway and the risks of missed cancers. The project also provides infrastructure to collect additional stool and blood samples to develop new tests that improve bowel cancer detection.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.