Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Significant Bowel Pathology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional FIT testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Additional FIT testing
- description
- Additional (3) FITs
- interventionNames
- Diagnostic Test: Additional FIT testing
Primary outcomes (1)
- measure
- Pathway diagnostic accuracy
- timeFrame
- One year
- description
- Diagnostic accuracy of multiple FIT testing pathway (sensitivity, specificity, NNI)
Secondary outcomes (3)
- measure
- Cost-per diagnosis
- timeFrame
- 1 year
- description
- Cost per diagnosis within the multiple FIT pathway
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
References
Publications (14)
- BACKGROUNDFlahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol. 2005 Aug;58(8):859-62. doi: 10.1016/j.jclinepi.2004.12.009. PMID 16018921
- BACKGROUNDLin JS, Perdue LA, Henrikson NB, Bean SI, Blasi PR. Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 May 18;325(19):1978-1998. doi: 10.1001/jama.2021.4417. PMID 34003220
- BACKGROUNDSeum T, Frick C, Cardoso R, Bhardwaj M, Hoffmeister M, Brenner H. Potential of pre-diagnostic metabolomics for colorectal cancer risk assessment or early detection. NPJ Precis Oncol. 2024 Oct 27;8(1):244. doi: 10.1038/s41698-024-00732-5. PMID 39462072
- BACKGROUNDFarkas NG, Palyvos L, O'Brien JW, Yu KS, Pigott C, Whyte M, Jourdan I, Rockall T, Fraser CG, Benton SC. The repeat FIT (RFIT) study: Does repeating faecal immunochemical tests provide reassurance and improve colorectal cancer detection? Colorectal Dis. 2024 Sep;26(9):1711-1719. doi: 10.1111/codi.17132. Epub 2024 Aug 13. PMID 39136046
- BACKGROUNDGerrard AD, Maeda Y, Noble C, Gunn F, Porteous L, Cheesbrough R, Thomson A, Dunlop MG, Din FVN; Edinburgh Colorectal Group. Clinical impact of double-faecal immunochemical testing following implementation into standard triage and investigation of primary care referrals in patients with lower gastrointestinal symptoms. BJS Open. 2025 Sep 8;9(5):zraf098. doi: 10.1093/bjsopen/zraf098. PMID 41061132
- BACKGROUNDLemmon 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
- 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.