Clinical trial · Interventional
Evaluation of Flexible Sigmoidoscopy Screening as an Adjunct to the National FOBT Screening Programme in Scotland
Evaluation of Flexible Sigmoidoscopy Screening as an Adjunct to the National FOBT Screening Programme in Scotland - A Random Evaluation
- 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)
Guaiac faecal occult blood testing (gFOBT) consistently demonstrates reductions in deaths from colorectal cancer of around 16% and gFOBT screening is now routine in all four countries of the United Kingdom. However, gFOBT has significant limitations and is associated with a substantial interval cancer rate in the region of 50 %, indicating a severe deficiency in sensitivity for cancer. Additionally, as the majority of colorectal cancers arise from pre-existing adenomas, it is important for colorectal screening programmes to detect adenomas in order to reduce the incidence of the disease as well as the associated mortality. Although gFOBT does detect some adenomas, most randomised trials have not demonstrated a reduction in colorectal cancer incidence. Also, FOBT screening tends to under-detect cancers in women and it is relatively insensitive for rectal cancer when compared with colon cancer. Single flexible sigmoidoscopy (FS), between the ages of 55 and 65 years, has been shown to bring about a significant reduction in colorectal cancer mortality. In addition, and most importantly, after a period of four years a significant reduction in colorectal cancer incidence was observed. FS does not suffer from low specificity since false positives do not occur, and there is independent evidence that it is more sensitive than a single gFOBT. In addition, FS is ideally suited to detecting rectal cancers and adenomas, and it is unlikely that there would be a gender difference in the sensitivity. Single FS has not been compared with biennial FOBT and there is no information regarding the utility of FS in a population that has already been exposed to FOBT screening. It is hypothesised that offering a combination of gFOBT and FS would provide an enhanced screening algorithm that would be associated with better outcomes than gFOBT alone. In order to test this hypothesis a randomised evaluation pilot study of FS screening integrated into the current gFOBT Screening Programme, will be carried out in those around age 60, as this appears to be the age at which adenoma prevalence peaks.
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 Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fecal occult blood test | Other | — | UNRESOLVED |
| Flexible Sigmoidoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Flexible Sigmoidoscopy
- description
- People randomized to this arm are offered flexible sigmoidoscopy in addition to FOBT at the age of 60.
- interventionNames
- Procedure: Flexible Sigmoidoscopy
- type
- PLACEBO_COMPARATOR
- label
- FOBT only
- description
- People in this are offered fecal occult blood testing only.
- interventionNames
- Other: Fecal occult blood test
Primary outcomes (1)
- measure
- Number of colorectal cancers or adenomas diagnosed
- timeFrame
- Within duration of study - two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 59 Years
- Maximum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible for colorectal screening Exclusion Criteria: * Absence of colon
References
Publications (22)
- BACKGROUNDBenson VS, Patnick J, Davies AK, Nadel MR, Smith RA, Atkin WS; International Colorectal Cancer Screening Network. Colorectal cancer screening: a comparison of 35 initiatives in 17 countries. Int J Cancer. 2008 Mar 15;122(6):1357-67. doi: 10.1002/ijc.23273. PMID 18033685
- BACKGROUNDHewitson P, Glasziou P, Watson E, Towler B, Irwig L. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol. 2008 Jun;103(6):1541-9. doi: 10.1111/j.1572-0241.2008.01875.x. Epub 2008 May 13. PMID 18479499
- BACKGROUNDHardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7. PMID 8942775
- BACKGROUNDKronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996 Nov 30;348(9040):1467-71. doi: 10.1016/S0140-6736(96)03430-7. PMID 8942774
- BACKGROUNDLindholm E, Brevinge H, Haglind E. Survival benefit in a randomized clinical trial of faecal occult blood screening for colorectal cancer. Br J Surg. 2008 Aug;95(8):1029-36. doi: 10.1002/bjs.6136. PMID 18563785
- BACKGROUNDSteele RJ, McClements PL, Libby G, Black R, Morton C, Birrell J, Mowat NA, Wilson JA, Kenicer M, Carey FA, Fraser CG. Results from the first three rounds of the Scottish demonstration pilot of FOBT screening for colorectal cancer. Gut. 2009 Apr;58(4):530-5. doi: 10.1136/gut.2008.162883. Epub 2008 Nov 26. PMID 19036949
- BACKGROUNDLeslie A, Carey FA, Pratt NR, Steele RJ. The colorectal adenoma-carcinoma sequence. Br J Surg. 2002 Jul;89(7):845-60. doi: 10.1046/j.1365-2168.2002.02120.x.