Evaluation the Diagnostic Ability of the Cancer Detection Technology (CDT) to Detect Breast Cancer Among Women Population Over Age 40
Recruitment status was: Not yet recruiting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation the Diagnostic Ability of the CDT to Detect Breast Cancer Among Women Population Over Age 40|
- To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40 [ Time Frame: one year ] [ Designated as safety issue: No ]
- To correlate the technology with standard test - screening mammography and biopsy [ Time Frame: two years ] [ Designated as safety issue: No ]
- To validate and compare the diagnostic ability of the CDT for detection of breast cancer [ Time Frame: two years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Breast Cancer Patients|
|Healthy Control Group|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043055
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Tamar Peretz, MD||Hadassah Medical Organization|