Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
29/05/2015
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 Atkin

ORCID ID

Contact details

Imperial College London
St. Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)20 7594 3350
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9615910

Study information

Scientific title

Multicentre randomised trial of 'once only' flexible sigmoidoscopy screening for prevention of bowel cancer morbidity and mortality

Acronym

UKFSST

Study hypothesis

Primary aims:
1. To quantify the reduction in incidence and mortality
2. To determine the duration of efficacy of a single flexible sigmoidoscopy
3. To determine the optimum age for the examination
4. To evaluate health service research implications to permit an informed decision at the end of the trial about the suitability for implementation within a national screening programme

The criteria to be evaluated include:
1. Uptake, acceptability and impact
2. Quality control of the procedure
3. Cost-effectiveness

On 28/02/2014 the following changes were made to the trial record:
1. The target number of participants field was changed from '195,000 - Recruitment ongoing' to 'Recruitment closed after randomising over 170,000 people'
2. The overall trial end date was changed from 31/12/2010 to 31/12/2015

Ethics approval

South East MREC approval (ref: MREC/03/1/002)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer

Intervention

'Once only' flexible sigmoidoscopy screening/control

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Incidence, mortality from colorectal cancer.

Secondary outcome measures

Psychological morbidity, costs to the NHS.

Overall trial start date

01/07/1995

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All 55-64 year old men and women from selected general practices

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Recruitment closed after randomising over 170,000 people

Participant exclusion criteria

1. If incapable of providing informed consent
2. Patients with a personal or family history of bowel cancer (greater than two family members)
3. A recent sigmoidoscopy or colonoscopy
4. Severe illness or life expectancy of less than 5 years

Recruitment start date

01/07/1995

Recruitment end date

28/02/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20430429

Publication citations

  1. Results

    Atkin WS, Edwards R, Kralj-Hans I, Wooldrage K, Hart AR, Northover JM, Parkin DM, Wardle J, Duffy SW, Cuzick J, , Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial., Lancet, 2010, 375, 9726, 1624-1633, doi: 10.1016/S0140-6736(10)60551-X.

Additional files

Editorial Notes