NCT01081288

Brief Summary

Nationwide cluster-randomised trial of extending the NHS breast screening age range in England

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000,000

participants targeted

Target at P75+ for not_applicable

Timeline
69mo left

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2009Dec 2031

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2010

Completed
21.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

22.6 years

First QC Date

March 3, 2010

Last Update Submit

December 11, 2025

Conditions

Breast Cancer Mortality

Keywords

Breast cancerBreast screeningMammographyRoutine screening programme

Outcome Measures

Primary Outcomes (1)

  • Breast cancer mortality

    17 years

Secondary Outcomes (3)

  • Breast cancer incidence, up to the same date that the primary outcome (breast cancer mortality) is reported

    17 years

  • Breast cancer treatments, including use of mastectomy, chemotherapy and radiotherapy, up to the same date that the primary outcome (breast cancer mortality) is reported

    17 years

  • All-cause mortality, up to the same date that the primary outcome (breast cancer mortality) is reported

    17 years

Study Arms (2)

Women aged 47-49 invited for breast screening

ACTIVE COMPARATOR
Other: Invitation for breast screening

Women aged 71-73 invited for breast screening

ACTIVE COMPARATOR
Other: Invitation for breast screening

Interventions

Invitation for breast screeningOTHER

Invitation for breast screening to women in different age groups

Women aged 47-49 invited for breast screeningWomen aged 71-73 invited for breast screening

Eligibility Criteria

Age47 Years - 73 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female, and
  • Aged 47-49 years or 71-73 years, and
  • In a Breast Screening Unit participating in the study. (All Breast Screening Units in England are expected to participate in the study with the exception of a few that use non-standard methods for creating screening batches).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Epidemiology Unit, Richard Doll Building, University of Oxford, Roosevelt Drive

Oxford, OX3 7LF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Toral Gathani, MD MBBS FRCS

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant Surgeon

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 5, 2010

Study Start

June 1, 2009

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

GB(1)