Clinical trial NCT01043055: Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40
Official title: Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer Screening
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 140
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients over age 40 before treatment. Healthy women recruited in Check Up institute from asymptomatic women over age 40, referred to screening mammography and received the negative result of mammography.

Brief summary: This study aimed to validate the diagnostic ability of the CDT (cancer detection technology) software to detect breast cancer among women population.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40
timeFrame: one year
Secondary outcomes:
measure: To correlate the technology with standard test - screening mammography and biopsy
timeFrame: two years
measure: To validate and compare the diagnostic ability of the CDT for detection of breast cancer
timeFrame: two years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Tamar Peretz, MD
role: PRINCIPAL_INVESTIGATOR
References: