Evaluation of Flexible Sigmoidoscopy Screening as an Adjunct to the National FOBT Screening Programme in Scotland

NCT02560194 | Completed

• 1 other identifier: 2013ON22
• Study Type: interventional
• Target: 4,567
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer; Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• Number of colorectal cancers or adenomas diagnosed

  Pathology report of lesion removed at flexible sigmoidoscopy or subsequent colonoscopy

  Within duration of study - two years

Secondary Outcomes (1)

• Number of invited individuals undergoing flexible sigmoidoscopy

  Within duration of study - two years

Study Arms (2)

Flexible Sigmoidoscopy

ACTIVE COMPARATOR

People randomized to this arm are offered flexible sigmoidoscopy in addition to FOBT at the age of 60.

Procedure: Flexible Sigmoidoscopy

FOBT only

PLACEBO COMPARATOR

People in this are offered fecal occult blood testing only.

Other: Fecal occult blood test

Interventions

Flexible Sigmoidoscopy PROCEDURE

Examination of the rectal and distal colon by means of a flexible endoscope

Flexible Sigmoidoscopy

Fecal occult blood test OTHER

Test for hemoglobin in faeces

FOBT only

Eligibility Criteria

• Age: 59 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible for colorectal screening

You may not qualify if:

• Absence of colon

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

NHS Tayside

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (22)

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  PMID: 22149740 BACKGROUND

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Occult Blood

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Robert JC Steele, MD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 25, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

GB (1)