Secondary Care Colorectal Cancer Pathway Review

NCT07430527 | Not Yet Recruiting

• 1 other identifier: AC26020
• Study Type: observational
• Target: 25,000
• 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 pickup rate (sensitivity) and reduces missed cancers. We successfully implemented this in NHS Lothian and contributed to national guidelines. This study will undertake a comprehensive retrospective review of the double-FIT urgent suspicion of bowel cancer pathway within NHS Lothian, from April 2022 (date of pathway inception) to August 2025, including around 25,000 patients that have been managed through the pathway. We will calculate key performance indicators and diagnostic accuracy of the pathway. Health economic analysis will determine cost-per-diagnosis. Risk factors for bowel cancer in this patient cohort will be identified to develop a support tool for primary and secondary-care. These results will be used to develop a future pathway to optimise pathway efficiency and cancer detection.

Conditions

Colorectal Cancer (Diagnosis)

Keywords

Faecal immunohistochemical test; FIT

Outcome Measures

Primary Outcomes (1)

• Pathway diagnostic accuracy

  Sensitivity, specificity, NNI of pathway

  1 year

Secondary Outcomes (1)

• Cost per diagnosis

  1 year

Study Arms (3)

FIT non-returners

Referred patients who did not return FIT

Single FIT returners

Referred patients who returned a single FIT

Diagnostic Test: Faecal Immunohistochemical test

Double FIT returners

Referred patients who returned two FITs

Diagnostic Test: Faecal Immunohistochemical test

Interventions

Faecal Immunohistochemical test DIAGNOSTIC_TEST

Faecal Immunohistochemical test

Double FIT returners; Single FIT returners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults referred to secondary-care with 'red-flag' gastrointestinal symptoms concerning for CRC.

You may qualify if:

• Patients managed within the NHS Lothian CRC USoC/urgent pathway (including urgent referrals) due to 'red-flag' symptoms concerning of CRC from April 2022 to August 2025.

You may not qualify if:

• Under the age of 18.
• History of inflammatory bowel disease.
• Under polyp surveillance.
• Previous diagnosis of CRC.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Related Publications (9)

• Perkmann T, Koller T, Perkmann-Nagele N, Ozsvar-Kozma M, Eyre D, Matthews P, Bown A, Stoesser N, Breyer MK, Breyer-Kohansal R, Burghuber OC, Hartl S, Aletaha D, Sieghart D, Quehenberger P, Marculescu R, Mucher P, Radakovics A, Klausberger M, Duerkop M, Holzer B, Hartmann B, Strassl R, Leitner G, Grebien F, Gerner W, Grabherr R, Wagner OF, Binder CJ, Haslacher H. Increasing test specificity without impairing sensitivity: lessons learned from SARS-CoV-2 serology. J Clin Pathol. 2023 Nov;76(11):770-777. doi: 10.1136/jcp-2022-208171. Epub 2022 Aug 30.

  PMID: 36041815 BACKGROUND

• Cubiella J, Vega P, Salve M, Diaz-Ondina M, Alves MT, Quintero E, Alvarez-Sanchez V, Fernandez-Banares F, Boadas J, Campo R, Bujanda L, Clofent J, Ferrandez A, Torrealba L, Pinol V, Rodriguez-Alcalde D, Hernandez V, Fernandez-Seara J; COLONPREDICT study investigators. Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients. BMC Med. 2016 Aug 31;14(1):128. doi: 10.1186/s12916-016-0668-5.

  PMID: 27580745 BACKGROUND

• Gerrard AD, Maeda Y, Miller J, Gunn F, Theodoratou E, Noble C, Porteous L, Glancy S, MacLean P, Pattenden R, Dunlop MG, Din FVN; Edinburgh Colorectal Group. Double faecal immunochemical testing in patients with symptoms suspicious of colorectal cancer. Br J Surg. 2023 Mar 30;110(4):471-480. doi: 10.1093/bjs/znad016.

  PMID: 36785496 BACKGROUND

• Saw KS, Liu C, Xu W, Varghese C, Parry S, Bissett I. Faecal immunochemical test to triage patients with possible colorectal cancer symptoms: meta-analysis. Br J Surg. 2022 Feb 1;109(2):182-190. doi: 10.1093/bjs/znab411.

  PMID: 34907419 BACKGROUND

• Pin-Vieito N, Tejido-Sandoval C, de Vicente-Bielza N, Sanchez-Gomez C, Cubiella J. Faecal immunochemical tests safely enhance rational use of resources during the assessment of suspected symptomatic colorectal cancer in primary care: systematic review and meta-analysis. Gut. 2022 May;71(5):950-960. doi: 10.1136/gutjnl-2021-324856. Epub 2021 Jun 9.

  PMID: 34108236 BACKGROUND

• Bailey JA, Ibrahim H, Bunce J, Chapman CJ, Morling JR, Simpson JA, Humes DJ, Banerjea A. Quantitative FIT stratification is superior to NICE referral criteria NG12 in a high-risk colorectal cancer population. Tech Coloproctol. 2021 Oct;25(10):1151-1154. doi: 10.1007/s10151-021-02466-z. Epub 2021 Jul 14.

  PMID: 34263362 BACKGROUND

• Cubiella J, Salve M, Diaz-Ondina M, Vega P, Alves MT, Iglesias F, Sanchez E, Macia P, Blanco I, Bujanda L, Fernandez-Seara J. Diagnostic accuracy of the faecal immunochemical test for colorectal cancer in symptomatic patients: comparison with NICE and SIGN referral criteria. Colorectal Dis. 2014 Aug;16(8):O273-82. doi: 10.1111/codi.12569.

  PMID: 24456168 BACKGROUND

• Farkas N, O'Brien JW, Palyvos L, Maclean W, Benton S, Rockall T, Jourdan I. The increasing burden of the 2-week wait colorectal cancer pathway in a single centre: the impact of faecal immunochemical tests. Ann R Coll Surg Engl. 2024 Apr;106(4):338-343. doi: 10.1308/rcsann.2022.0138. Epub 2023 Jan 23.

  PMID: 36688865 BACKGROUND

• Lemmon E, Hanna C, Diernberger K, Paterson HM, Wild SH, Ennis H, Hall PS. Variation in colorectal cancer treatment and outcomes in Scotland: real world evidence from national linked administrative health data. Int J Popul Data Sci. 2024 Feb 20;9(1):2179. doi: 10.23889/ijpds.v6i1.2179. eCollection 2024.

  PMID: 38476269 BACKGROUND

Related Links

• Cancer Research UK (CRUK). Bowel cancer statistics \[Internet\]. Cancer Research UK. Published 2024
• The Scottish Government. Quantitative Faecal Immunochemical Test (qFIT) for Patients with Colorectal Symptoms Guidance for Primary Care \[Internet\]. The Scottish Government. Published 2022
• 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; Disease

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2030
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)