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Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer Clinical research trials and Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer. Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer  Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer
Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): American College of Radiology Imaging Network , National Cancer Institute (NCI)
Synopsis: RATIONALE: Screening tests, such as ultrasonography and mammography, may help doctors detect cancer cells early and plan more effective treatment for breast cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of breast ultrasonography plus mammography with that of mammography alone in detecting cancer in women who are at high risk for breast cancer.
Details: OBJECTIVES: Primary - Compare the diagnostic yield of whole breast bilateral screening ultrasonography with mammography vs mammography alone in the detection of breast cancer in women at high risk for breast cancer. Secondary - Compare the sensitivity and specificity of these screening methods in these participants. - Correlate performance of these screening methods with selected participant characteristics (e.g., breast density and heterogeneity of the parenchyma). - Validate the sonographic classification of lesions as "probably benign" and estimate the rate of malignancy in participants screened with these methods. - Compare the quality of life of participants who undergo these screening methods. - Determine the cost effectiveness associated with screening breast ultrasonography. - Determine the reproducibility of lesion identification, measurement of lesion diameters, and volume and recording of lesion location on sonography in participants screened with these methods. OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2 screening arms. - Arm I: Participants undergo physician-performed bilateral whole breast ultrasound followed by mammogram within 2 weeks. - Arm II: Participants undergo mammogram followed by physician-performed bilateral whole breast ultrasound within 2 weeks. In both arms, participants with negative or benign findings are rescreened according to their screening arm at 1 and 2 years. Participants with "probably benign" findings are rescreened at 6 months. Participants with findings that are suspicious or highly suggestive of malignancy are recommended for biopsy. Quality of life is assessed at baseline, 1 month, and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 3,000 participants will be accrued for this study within 2 years.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 25 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - At high risk for breast cancer, as defined by at least 1 of the following: - Known BRCA1 or BRCA2 mutation - Personal history of breast cancer with conserved breast analyzed separately - Prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, or atypical papilloma and not receiving chemoprevention OR any of these atypical lesions AND first-degree relative diagnosed with breast cancer under age 50 - Prior biopsy showing lobular carcinoma in situ - Age 30 and under and received prior chest and/or mediastinal and/or axillary irradiation at least 8 years ago - Gail or Claus lifetime cancer risk at least 25% - Heterogeneously dense or extremely dense breast parenchyma in at least 1 breast by mammogram* OR unknown breast density due to no prior mammogram NOTE: *No fatty breasts or minimal scattered fibroglandular density - No current signs or symptoms of breast cancer (e.g., palpable breast masses, bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast[s] or nipple[s]) - No breast implants - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 25 and over 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 or nursing - Fertile patients must use effective contraception - Able to undergo adequate mammography and cooperate with breast ultrasonography - No concurrent medical or psychiatric condition that would preclude biopsy - No malignancy within the past 5 years except breast cancer diagnosed at least 1 year ago with no known distant metastases, basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics - More than 1 year since prior fine needle aspiration, core needle biopsy, or surgical procedure Other - More than 1 year since prior contrast-enhanced MRI of the breast - More than 1 year since prior whole breast bilateral sonography - More than 1 year since prior sonographic or mammographic contrast agent injection or tomosynthesis - No concurrent participation in any other breast cancer screening trial - No concurrent participation in any study involving breast MRI, sonographic or mammographic contrast agents, or tomosynthesis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WendieBerg, Study Chair, Sidney Kimmel Cancer Center
Weinstein Imaging Associates *Recruiting*
Pittsburgh, Pennsylvania, 15206
United States
Recruiting Marcela Bohm-Velez 412-441-1161
Additional Information:
Study ID Numbers: CDR0000339812; ACRIN-6666
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072501
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2. Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
3. Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced or Metastatic Breast Cancer
4. LY353381 in Preventing Breast Cancer in Women With Hyperplasia
5. Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
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Breast Ultrasonography and Mammography in Screening Women at High Risk for Breast Cancer
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