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NCT07430540Recruiting

Optimising Colorectal Cancer Patient Pathways

Optimising Patient Pathways for Earlier Detection of Colorectal Cancer in Secondary Care: Implementation of Multiple FIT Testing

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
18 Feb 2026
Start date
5 Jun 2026
Primary completion date
22 Mar 2028
Lead sponsor
University of Edinburgh
NCT number
NCT07430540

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 5 Jun 2026 to the primary completion date, 22 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous history of CRC or IBD, or under polyp surveillance

Other illness

  • Known to have genetic hereditary condition predisposing patient to increased risk of CRC (e.g. Lynch, FAP, etc).

Other

  • Two negative FITs on referral
  • Patients referred with a palpable rectal or abdominal mass

Who the study is looking for

  • Patients referred to the NHS Lothian USoC CRC pathway or an urgent referral with 'red-flag' symptoms, and with a positive FIT on referral will be included.
  • Referred from start date of study, for up to 1 year

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NHS Lothian
Coordinator of this site? Confirm its status
EdinburghUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.