Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40
|ClinicalTrials.gov Identifier: NCT01043055|
Recruitment Status : Unknown
Verified October 2009 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : January 6, 2010
Last Update Posted : January 6, 2010
|Condition or disease|
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:
- Mathematical processing of specific blood analysis in device Flowcytometer.
- Mathematical evaluation of specific prognostic parameters
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||January 2011|
|Breast Cancer Patients|
|Healthy Control Group|
- To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40 [ Time Frame: one year ]
- To correlate the technology with standard test - screening mammography and biopsy [ Time Frame: two years ]
- To validate and compare the diagnostic ability of the CDT for detection of breast cancer [ Time Frame: two years ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043055
|Contact: Tamar Peretz, MD||6777825 ext firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||6777572 ext email@example.com|
|Hadassah Medical Organization||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DmD 6776095 ext 009722 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 6777572 ext 009722 Lhadas@hadassah.org.il|
|Sub-Investigator: Benjamin Nisman, PhD|
|Sub-Investigator: Tamar Sella, MD|
|Sub-Investigator: Tzeela Cohen, MD|
|Sub-Investigator: Oded Zamir, MD|
|Principal Investigator:||Tamar Peretz, MD||Hadassah Medical Organization|