Submission date
06/04/2000
Registration date
06/04/2000
Last edited
19/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

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/CTIS number

IRAS number

ClinicalTrials.gov number

Secondary identifying numbers

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(s)

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study 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

Primary outcome measure

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 study start date

30/07/1990

Overall study end date

31/12/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Women aged 40-41 identified from Health Authorities registers

Participant type(s)

Patient

Age group

Adult

Sex

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

England, United Kingdom

Study 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 (0)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)

UK Medical Research Council, MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

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

Individual participant data (IPD) Intention to share

No

IPD sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/07/1999 Yes No
Other publications Implications of pathologist concordance 01/03/2002 Yes No
Results article results 09/12/2006 Yes No
Other publications assessment of contamination in the control group: 01/04/2010 Yes No
Results article results 01/09/2015 Yes No
Results article results 01/04/2016 Yes No
Results article results 01/09/2020 19/08/2020 Yes No

Additional files

Editorial Notes

19/08/2020: Publication reference added. 08/02/2016: Publication reference added.