|
ISRCTN
|
ISRCTN24647151
|
|
DOI
|
10.1186/ISRCTN24647151
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
UKCCCR trial to study the effect on breast cancer mortality of annual mammographic screening starting at age 40
|
|
Scientific title
|
|
|
Acronym
|
The 'Age' trial
|
|
Serial number at source
|
G9000793
|
|
Study hypothesis
|
To determine the effectiveness of mammographic screening starting at age 40, compared with starting at age 50, in reducing mortality from breast cancer.
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Ethics approval from Central London REC 98/2/40.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Breast cancer
|
|
Participants - inclusion criteria
|
Women aged 40-41 identified from Health Authorities registers
|
|
Participants - exclusion criteria
|
Women under care for breast cancer may be removed from the prior notification list by the GPs prior to randomisation
|
|
Anticipated start date
|
30/07/1990
|
|
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 ceased at 160,000. Closed to recruitment - in follow-up.
|
|
Interventions
|
Women in the intervention group are offered annual screening by mammography until the year of their 48th birthday. Screening is by 2-view mammography at 1st screen and single view subsequently. All women in both intervention and control groups will be invited for screening in the NHSBSP between the age of 50-52.
|
|
Primary outcome measure(s)
|
Deaths from breast cancer in women free of the disease at trial entry in the two groups. Information on prognostic factors of all breast cancers is also collected.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
1. Medical Research Council (MRC) (UK)
2. Long -term follow up funded by National Institute for Health Research (NIHR) / Health Technology Assessment (HTA)
|
|
Trial website
|
|
|
Publications
|
1. 1999 protocol in http://www.ncbi.nlm.nih.gov/pubmed/10572845
2. 2002 Implications of pathologist concordance in http://www.ncbi.nlm.nih.gov/pubmed/11979379
3. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17161727
4. 2010 assessment of contamination in the control group http://www.ncbi.nlm.nih.gov/pubmed/20233850
|
|
Contact name
|
Dr
Sue
Moss
|
|
Address
|
Professor of Cancer Epidemiology
Centre for Cancer Prevention
Queen Mary University of London
Wolfson Institute of Preventive Medicine Charterhouse Square London
|
|
City/town
|
London
|
|
Zip/Postcode
|
EC1M 6BQ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 207 882 5841
|
|
Email
|
s.moss@qmul.ac.uk
|
|
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
|
12/06/2012
|
|
Date ISRCTN assigned
|
06/04/2000
|
