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ISRCTN
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ISRCTN02411483
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ClinicalTrials.gov identifier
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Public title
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Study of colonoscopic surveillance intervals after removal of colorectal adenomas
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Scientific title
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Randomised trial of colonoscopic surveillance intervals after removal of colorectal adenomas
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Acronym
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N/A
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Serial number at source
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HTA 04/33/01
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Study hypothesis
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The study was designed to compare the effectiveness of different frequencies of colonoscopic examination, with polypectomy of all adenomas detected, for preventing advanced adenomas and colorectal cancer (CRC).
A secondary aim of this study was to identify baseline risk factors for diagnosis of advanced neoplasia (adenomas and CRC) during follow-up. This approach was adopted to determine if a subgroup of patients might benefit from more intense surveillance.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not applicable because ethical approval standards were not in place when the study was started in the late 1970s – early 1980s.
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Study design
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Single-centre stratified randomised trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Colorectal cancer
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Participants - inclusion criteria
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1. Patients attending St Mark’s Hospital between 1979-1990, with endoscopically removed adenomas or malignant lesions
2. 468 males and 317 females in the study, aged between 20 and 71
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Participants - exclusion criteria
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1. History of inflammatory bowel disease
2. Surgical resection for CRC
3. A rectal villous adenoma
4. Patients older than 70 years
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Anticipated start date
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01/01/1979
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Anticipated end date
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01/01/1990
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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785 patients were recruited
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Interventions
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Study of colonoscopic surveillance regimens. Allocation to regimen was by minimisation method. Patients were stratified into high and low risk groups by their characteristics at entry (age, malignancy and multiplicity of adenomas). Then within the high risk group the participants could be randomised to frequent follow-up or exams at three year intervals. Within the low risk group paricipants could be randomised to exams at three year intervals or exams at five year intervals. No masking, all participants received surveillance.
High risk patients:
Three exams at 12-18 month intervals and 3-yearly follow-up thereafter (median endoscopic surveillance - 7.0 yrs, median passive follow-up - 18.6 yrs) or exams at three year intervals (median endoscopic surveillance - 6.6 yrs, median passive follow-up - 18.8 yrs)
Low risk patients:
Exams at three year intervals (median endoscopic surveillance - 9.1 yrs, median passive follow-up - 21.7 yrs) or exams at five year intervals (median endoscopic surveillance - 6.3 yrs, median passive follow-up - 21.8 yrs)
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Primary outcome measure(s)
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The primary outcome was the diagnosis of advanced neoplasia (advanced adenomas or colorectal cancer) during follow-up. An advanced adenoma was defined as an adenoma ≥ 10 mm or with high grade dysplasia.
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Secondary outcome measure(s)
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Detection of any adenoma during follow-up.
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Sources of funding
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1. NIHR Health Technology Assessment Programme - HTA (UK) (HTA 04/33/01)
2. Cancer Research UK (CRUK) (UK) (grant numbers C8649/A7479, C8171/A7699)
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Trial website
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Publications
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Contact name
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Prof
Wendy S
Atkin
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Address
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Imperial College London
St. Mary's Campus
Norfolk Place
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City/town
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London
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Zip/Postcode
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W2 1PG
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Country
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United Kingdom
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Tel
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+44 (0)20 7594 3369
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Fax
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+44 (0)20 7594 3051
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Email
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w.atkin@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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Clinical Research Governance Office
G02, Sir Alexander Fleming Building
South Kensington Campus
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Tel
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+44 (0)20 7594 1554
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Fax
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+44 (0)20 7594 1792
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Email
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clinicalresearchgovernanceoffice@imperial.ac.uk
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Date applied
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07/06/2011
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Last edited
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08/06/2011
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Date ISRCTN assigned
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08/06/2011
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