Condition category
Cancer
Date applied
07/06/2011
Date assigned
08/06/2011
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wendy S Atkin

ORCID ID

Contact details

Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3369
w.atkin@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 04/33/01

Study information

Scientific title

Randomised trial of colonoscopic surveillance intervals after removal of colorectal adenomas

Acronym

Study hypothesis

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.

Ethics approval

Not applicable because ethical approval standards were not in place when the study was started in the late 1970s – early 1980s.

Study design

Single-centre stratified randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Colorectal cancer

Intervention

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)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

Detection of any adenoma during follow-up.

Overall trial start date

01/01/1979

Overall trial end date

01/01/1990

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

785 patients were recruited

Participant exclusion criteria

1. History of inflammatory bowel disease
2. Surgical resection for CRC
3. A rectal villous adenoma
4. Patients older than 70 years

Recruitment start date

01/01/1979

Recruitment end date

01/01/1990

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Clinical Research Governance Office
G02
Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom
+44 (0)20 7594 1554
clinicalresearchgovernanceoffice@imperial.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (HTA 04/33/01)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cancer Research UK (CRUK) (UK) (grant numbers C8649/A7479, C8171/A7699)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/03/2016: No publications found, verifying study status with principal investigator.