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Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40

40 Years
90 Years
Not Enrolling
Breast Cancer

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Trial Information

Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40

Breast cancer diagnosis is a rapidly expanding research field, whose early-stage detection
may reduce the burden of the disease and permit more effective treatment. It is well
documented that tumor growth requires specific conditions for its development from the
occurrence of a mutation to a clinically detectable cancer. It has been shown that living
peripheral blood mononuclear cells (PBMC) have different ability of cytosolic enzymes
(esterases) to convert hydrophobic substrate fluorescein diacetate (FDA) into hydrophilic
fluorescent fluorescein. It depends on PBMC cycle stage, size, surface state, physiological
states, such as activation and apoptosis.

The important step of breast cancer genesis is the early change of functional activity of
cytosolic enzymes (esterases) in peripheral blood mononuclear cells. Such transformations in
PBMC may be detected accurately by an existing device Flowcytometer (FACS™ MultiSET™ System,
company "Becton Dickinson" GmbH, USA), where measurements of fluorescence polarization and
enzymatic hydrolysis of FDA substrate are recorded. A conclusion about presentation of
breast cancer among examined women is achieved by "CDT" (cancer detection technology)
software, which analyzes mathematically the results of fluorescence polarization and
enzymatic hydrolysis.

Moreover, the combined biochemical model together with additional prognostic parameters
(such as age, ethnic group, gynecological and obstetric anamnesis) increases the validity
(accuracy, sensitivity and specificity) of the diagnostic conclusion.

Diagnostic Solution of the CDT:

1. Mathematical processing of specific blood analysis in device Flowcytometer.

2. Mathematical evaluation of specific prognostic parameters

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Tamar Peretz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization


Israel: Ministry of Health

Study ID:




Start Date:

January 2010

Completion Date:

January 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer Screening
  • Breast Neoplasms