Optimising Colorectal Cancer Patient Pathways

NCT07430540 | Not Yet Recruiting

• 1 other identifier: AC26021
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Significant Bowel Pathology

Keywords

colorectal cancer; Multiple testing; Diagnostic accuracy; Faecal Immunohistochemical Test; qFIT

Outcome Measures

Primary Outcomes (1)

• Pathway diagnostic accuracy

  Diagnostic accuracy of multiple FIT testing pathway (sensitivity, specificity, NNI)

  One year

Secondary Outcomes (3)

• Cost-per diagnosis

  1 year

• Re-referral rate

  2 years

• Interval CRC rate

  2 years

Study Arms (1)

Additional FIT testing

EXPERIMENTAL

Additional (3) FITs

Diagnostic Test: Additional FIT testing

Interventions

Additional FIT testing DIAGNOSTIC_TEST

Additional (3) FIT tests

Additional FIT testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Two negative FITs on referral
• Patients referred with a palpable rectal or abdominal mass
• Previous history of CRC or IBD, or under polyp surveillance
• Known to have genetic hereditary condition predisposing patient to increased risk of CRC (e.g. Lynch, FAP, etc).

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Related Publications (14)

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Related Links

• Cancer Research UK (CRUK). Bowel cancer statistics \[Internet\]. Cancer Research UK. Published 2024
• National Institute for Health and Care Research. Clinical decision support tools. \[Internet\]. National Institute for Health and Care Research. Published 2020

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be recruited to provide three additional FITs to standard double-FIT care. Diagnostic accuracy analysis will be conducted on the single group of patients providing additional FITs. Diagnostic accuracy comparisons will be made between the included group and the group that have declined intervention.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): March 22, 2028
• Study Completion (Estimated): March 22, 2037
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

GB (1)