Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-04 @ 6:58 AM
Study NCT ID:
NCT00450359
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2007-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SCREENING'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-01', 'studyFirstSubmitDate': '2007-03-20', 'studyFirstSubmitQcDate': '2007-03-20', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast cancer detection rate'}, {'measure': 'Recall rate'}], 'secondaryOutcomes': [{'measure': 'Film reader performance using computer-aided detection'}]}, 'conditionsModule': {'keywords': ['breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '20656831', 'type': 'RESULT', 'citation': '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': '18832239', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.', 'detailedDescription': "OBJECTIVES:\n\n* Compare, prospectively, the breast cancer detection rate and recall rate of single reading using computer-aided detection vs standard double reading in women undergoing screening mammography.\n\nOUTLINE: This is a prospective, randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.\n\n* Arm I (double reading): Screening mammograms are independently reviewed by two readers (i.e., radiologist or radiographer), each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. In the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the mammogram and making the final decision to recall the participant or return to routine screening.\n* Arm II (single reading with computer-aided detection \\[CAD\\]): Screening mammograms are reviewed initially by a single reader who reports on any abnormalities. The reader then re-examines the mammogram with the aid of CAD, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. Based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening. If there is a discrepancy between the reader's interpretation and the CAD findings, another reader may be consulted to review the mammogram.\n* Arm III (double reading followed by single reading with CAD): Screening mammograms are reviewed by double reading as in arm I followed by single reading with CAD as in arm II.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 30,000 participants will be accrued for this study."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Currently undergoing 2-view mammography for routine breast cancer screening at any of the following participating National Health Services Breast Cancer Screening Program centers:\n\n * Manchester\n * Coventry\n * Nottingham\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00450359', 'briefTitle': 'Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Prospective Evaluation of Computer Aided Detection (CAD) in the NHS Breast Screening Programme [CADET II]', 'orgStudyIdInfo': {'id': 'ABROIN-06-MRE01-14'}, 'secondaryIdInfos': [{'id': 'CDR0000534404', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'CRUK-CADET-II'}, {'id': 'ABROIN-CADET-II'}, {'id': 'EU-20709'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'breast imaging study', 'type': 'PROCEDURE'}, {'name': 'comparison of screening methods', 'type': 'PROCEDURE'}, {'name': 'radiomammography', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CV2 2DX', 'city': 'Coventry', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Walsgrave Hospital', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'M20 8LR', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Withington Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Fiona Gilbert, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aberdeen Royal Infirmary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aberdeen Royal Infirmary', 'class': 'OTHER'}}}}