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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02560194
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
Professor Robert J C Steele, University of Dundee

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colorectal Adenoma Procedure: Flexible Sigmoidoscopy Other: Fecal occult blood test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4567 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Flexible Sigmoidoscopy Screening as an Adjunct to the National FOBT Screening Programme in Scotland - A Random Evaluation
Study Start Date : June 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: Flexible Sigmoidoscopy
People randomized to this arm are offered flexible sigmoidoscopy in addition to FOBT at the age of 60.
Procedure: Flexible Sigmoidoscopy
Examination of the rectal and distal colon by means of a flexible endoscope

Placebo Comparator: FOBT only
People in this are offered fecal occult blood testing only.
Other: Fecal occult blood test
Test for hemoglobin in faeces

Primary Outcome Measures :
  1. Number of colorectal cancers or adenomas diagnosed [ Time Frame: Within duration of study - two years ]
    Pathology report of lesion removed at flexible sigmoidoscopy or subsequent colonoscopy

Secondary Outcome Measures :
  1. Number of invited individuals undergoing flexible sigmoidoscopy [ Time Frame: Within duration of study - two years ]
    Record of whether or not the flexible sigmoidoscopy had been carried out

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Eligible for colorectal screening

Exclusion Criteria:

  • Absence of colon

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02560194

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United Kingdom
NHS Tayside
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
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Principal Investigator: Robert JC Steele, MD University of Dundee

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Responsible Party: Professor Robert J C Steele, Professor of Surgery, University of Dundee Identifier: NCT02560194    
Other Study ID Numbers: 2013ON22
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type