Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
08/02/2016
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

Dr Sue Moss

ORCID ID

Contact details

Professor of Cancer Epidemiology
Centre for Cancer Prevention
Queen Mary University of London
Wolfson Institute of Preventive Medicine Charterhouse Square London
London
EC1M 6BQ
United Kingdom
+44 (0)207 882 5841
s.moss@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9000793

Study information

Scientific title

UKCCCR trial to study the effect on breast cancer mortality of annual mammographic screening starting at age 40

Acronym

The 'Age' trial

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.

Ethics approval

Ethics approval from Central London REC 98/2/40.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Breast cancer

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

30/07/1990

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 40-41 identified from Health Authorities registers

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

195,000. Recruitment ceased at 160,000

Participant exclusion criteria

Women under care for breast cancer may be removed from the prior notification list by the GPs prior to randomisation

Recruitment start date

30/07/1990

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Mary University of London
London
EC1M 6BQ
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

Funder name

Long-term follow up funded by National Institute for Health Research (NIHR) / Health Technology Assessment (HTA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1999 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/10572845
2002 Implications of pathologist concordance in: http://www.ncbi.nlm.nih.gov/pubmed/11979379
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/17161727
2010 assessment of contamination in the control group: http://www.ncbi.nlm.nih.gov/pubmed/20233850
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26206144
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26847236

Publication citations

  1. Protocol

    Moss S, A trial to study the effect on breast cancer mortality of annual mammographic screening in women starting at age 40. Trial Steering Group., J Med Screen, 1999, 6, 3, 144-148.

  2. Implications of pathologist concordance

    Anderson TJ, Sufi F, Ellis IO, Sloane JP, Moss S, Implications of pathologist concordance for breast cancer assessments in mammography screening from age 40 years., Hum. Pathol., 2002, 33, 3, 365-371.

  3. Results

    Moss SM, Cuckle H, Evans A, Johns L, Waller M, Bobrow L, , Effect of mammographic screening from age 40 years on breast cancer mortality at 10 years' follow-up: a randomised controlled trial., Lancet, 2006, 368, 9552, 2053-2060, doi: 10.1016/S0140-6736(06)69834-6.

  4. Assessment of contamination in the control group

    Kingston N, Thomas I, Johns L, Moss S, , Assessing the amount of unscheduled screening ("contamination") in the control arm of the UK "Age" Trial., Cancer Epidemiol. Biomarkers Prev., 2010, 19, 4, 1132-1136, doi: 10.1158/1055-9965.EPI-09-0996.

  5. Results

    Moss SM, Wale C, Smith R, Evans A, Cuckle H, Duffy SW, Effect of mammographic screening from age 40 years on breast cancer mortality in the UK Age trial at 17 years' follow-up: a randomised controlled trial, Effect of mammographic screening from age 40 years on breast cancer mortality in the UK Age trial at 17 years' follow-up: a randomised controlled trial, 2015 , doi: 10.1016/S1470-2045(15)00128-X.

  6. Results

    Busana MC, De Stavola BL, Sovio U, Li J, Moss S, Humphreys K, Dos-Santos-Silva I, Assessing within-woman changes in mammographic density: a comparison of fully versus semi-automated area-based approaches, Cancer Causes Control, 2016 .

Additional files

Editorial Notes

08/02/2016: Publication reference added.