NCT00450359

Brief Summary

RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography. PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30,000

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

4 active sites

Status
completed

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 Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 2, 2013

Status Verified

October 1, 2008

First QC Date

March 20, 2007

Last Update Submit

August 1, 2013

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

  • Breast cancer detection rate

  • Recall rate

Secondary Outcomes (1)

  • Film reader performance using computer-aided detection

Interventions

breast imaging studyPROCEDURE
comparison of screening methodsPROCEDURE
radiomammographyPROCEDURE

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Currently undergoing 2-view mammography for routine breast cancer screening at any of the following participating National Health Services Breast Cancer Screening Program centers: * Manchester * Coventry * Nottingham * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Withington Hospital

Manchester, England, M20 8LR, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Related Publications (2)

  • James JJ, Gilbert FJ, Wallis MG, Gillan MG, Astley SM, Boggis CR, Agbaje OF, Brentnall AR, Duffy SW. Mammographic features of breast cancers at single reading with computer-aided detection and at double reading in a large multicenter prospective trial of computer-aided detection: CADET II. Radiology. 2010 Aug;256(2):379-86. doi: 10.1148/radiol.10091899.

    PMID: 20656831RESULT

  • Gilbert FJ, Astley SM, Gillan MG, Agbaje OF, Wallis MG, James J, Boggis CR, Duffy SW; CADET II Group. Single reading with computer-aided detection for screening mammography. N Engl J Med. 2008 Oct 16;359(16):1675-84. doi: 10.1056/NEJMoa0803545. Epub 2008 Oct 1.

    PMID: 18832239RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Fiona Gilbert, MD

    Aberdeen Royal Infirmary

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SCREENING
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

September 1, 2006

Study Completion

October 1, 2008

Last Updated

August 2, 2013

Record last verified: 2008-10

Locations

GB(4)