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

NCT ID: NCT01043055

Last Updated: 2010-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Cancer Patients

No interventions assigned to this group

Healthy Control Group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah Medical Organization

Principal Investigators

Tamar Peretz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, Jerusalem, Israel

Countries

Israel

Central Contacts

Tamar Peretz, MD

Role: CONTACT

tamary@hadassah.org.il

6777825 ext. 009722

Hadas Lemberg, PhD

Role: CONTACT

lhadas@hadassah.org.il

6777572 ext. 009722

Facility Contacts

Arik Tzukert, DmD

Role: primary

arik@hadassah.org.il

6776095 ext. 009722

Hadas Lemberg, PhD

Role: backup

Lhadas@hadassah.org.il

6777572 ext. 009722

Other Identifiers

044809-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id