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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer

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

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Control Group
Breast Cancer Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
To correlate the technology with standard test - screening mammography and biopsy	two years
To validate and compare the diagnostic ability of the CDT for detection of breast cancer	two years

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Tamar Peretz, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2010
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: January 5, 2010
• First Submitted That Met QC Criteria: January 5, 2010
• First Posted (Estimate): January 6, 2010

Study Record Updates

• Last Update Posted (Estimate): January 6, 2010
• Last Update Submitted That Met QC Criteria: January 5, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Breast Cancer Screening
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 044809-HMO-CTIL