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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01043055
• Other study ID #: 044809-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 5, 2010
• Last updated: January 5, 2010
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2009
• Source: Hadassah Medical Organization
• Contact: Tamar Peretz, MD
• Phone: 6777825
• Email: tamary[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

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