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Home > "S" Clinical Trials Conditions > Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women  Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
For Condition: Breast Cancer
Status: No longer recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known which type of mammography is more effective in detecting breast cancer. PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of mammography in detecting breast cancer in women.
Details: OBJECTIVES: - Compare the diagnostic performance of digital mammography vs screen-film mammography, as measured by the area under the Receiver Operating Characteristic (ROC) curve, sensitivity, specificity, and positive and negative predictive values, in the detection of breast cancer in women. - Compare the diagnostic accuracy of the digital mammogram obtained using each of the individual manufacturer's digital units vs screen-film mammography through retrospective reader studies. - Determine the effects of patient characteristics, including age, lesion type, pathologic diagnosis, menopausal and hormonal status, breast density, and family history, on diagnostic accuracy of digital mammography. - Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography. - Determine the effect of reduced false-positive mammograms that are expected with digital mammography on the health-related quality of life and personal anxiety of women undergoing this screening experience. - Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study. - Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study. - Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study. - Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants. - Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers. OUTLINE: This is a randomized, multicenter study. Participants with postitive screening results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70). Participants are randomized to one of two treatment arms. - Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view digital mammogram of each breast. - Arm II: Participants undergo a two-view digital mammogram followed by a two-view screen-film mammogram of each breast. Quality of life is assessed before the screening mammogram in the first 800 women enrolled. In an additional 1,200 participants (600 with positive screening results and 600 with negative screening results), quality of life is assessed shortly after the screening mammogram and at 1 year. Participants are followed at 1 year with a repeat screen-film or digital mammogram. PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Asymptomatic women presenting for screening mammography - No focal dominant lump or bloody or clear nipple discharge - No prior breast cancer treated with lumpectomy - Prior mastectomy for breast cancer allowed - No breast implants - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - Any age Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EttaPisano, Study Chair, UNC Lineberger Comprehensive Cancer Center
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
Shore Memorial Hospital
Somers Point, New Jersey, 08244
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
United States
Elizabeth Wende Breast Clinic
Rochester, New York, 14620
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-8585
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0772
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60610
United States
Mount Sinai School of Medicine
New York City, New York, 10029-6574
United States
Washington Radiology Associates, P.C.
Washington D.C., District of Columbia, 20037
United States
Emory Health Care Clinic
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599
United States
University of Washington Medical Center
Seattle, Washington, 98112
United States
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, M4N 3M5
Canada
La Grange Memorial Hospital
La Grange, Illinois, 60525
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10003
United States
Additional Information:
Study ID Numbers: CDR0000068399; ACRIN-6652
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008346
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Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
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