|
ISRCTN
|
ISRCTN28352761
|
|
DOI
|
10.1186/ISRCTN28352761
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Multicentre randomised trial of 'once only' flexible sigmoidoscopy screening for prevention of bowel cancer morbidity and mortality
|
|
Scientific title
|
|
|
Acronym
|
UKFSST
|
|
Serial number at source
|
G9615910
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Added 10/08/09: South East MREC approval (ref: MREC/03/1/002)
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Colorectal cancer
|
|
Participants - inclusion criteria
|
All 55-64 year old men and women from selected general practices
|
|
Participants - 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
|
|
Anticipated start date
|
01/07/1995
|
|
Anticipated end date
|
31/12/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
195,000 - Recruitment ongoing.
|
|
Interventions
|
'Once only' flexible sigmoidoscopy screening/control
|
|
Primary outcome measure(s)
|
Incidence, mortality from colorectal cancer.
|
|
Secondary outcome measure(s)
|
Psychological morbidity, costs to the NHS.
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20430429
|
|
Contact name
|
Prof
Wendy
Atkin
|
|
Address
|
Imperial College London
St. Mary's Campus
Norfolk Place
|
|
City/town
|
London
|
|
Zip/Postcode
|
W2 1PG
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7594 3350
|
|
Fax
|
+44 (0)20 7594 3051
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
06/04/2000
|
|
Last edited
|
26/05/2010
|
|
Date ISRCTN assigned
|
06/04/2000
|
