Breast Cancer Clinical Trial
Official title:
Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40
This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | January 2011 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 90 Years |
Eligibility |
Inclusion Criteria: Inclusion Criteria for Breast Cancer Patients for Experimental Group: 1. Patient is over the age of 40. 2. Patient is willing to participate as evidenced by signing the written informed consent form. 3. Patient referred to the Department of Oncology/ Surgery for operative treatment of breast cancer with previously detected disease. Positive conventional tests finding can include (but not limited to) the record of screening or diagnostic mammography, blood oncomarkers, breast ultrasound, breast CT, biopsy. 4. Non-treated patients (w/o previous chemotherapy, hormonal drugs and radiotherapy). 5. Patient without other cancer locations Inclusion Criteria for Presumably Healthy Subjects for Control Group: 1. Subjects over the age of 40. 2. Subjects who are willing to participate as evidenced by signing the written informed consent form. 3. Subjects who are presumably healthy and without breast pathologies' symptoms and family history of breast cancer, i.e., breast disease (except history of functional breast problems, e.g., mastitis within lactation period) has been ruled out based on physician anamnesis 4. Subjects with negative results of screening mammography. 5. Subjects without taking of any hormonal medicines Exclusion Criteria: 1. Subjects with any known cancer in other internal organs or systems. 2. Subjects with high fever presentation (more than 38.5). 3. Subjects with known breast disease undergoing treatment for the disease. 4. Pregnant or lactating women |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40 | one year | No | |
Secondary | To correlate the technology with standard test - screening mammography and biopsy | two years | No | |
Secondary | To validate and compare the diagnostic ability of the CDT for detection of breast cancer | two years | No |
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