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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01043055
Collaborator
(none)
140
Enrollment
1
Location
12
Duration (Months)
11.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    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
    Study Start Date :
    Jan 1, 2010
    Anticipated Primary Completion Date :
    Jan 1, 2010
    Anticipated Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Breast Cancer Patients
    Healthy Control Group

    Outcome Measures

    Primary Outcome Measures

    1. To validate the diagnostic ability of the CDT to detect breast cancer among women population over age 40 [one year]

    Secondary Outcome Measures

    1. To correlate the technology with standard test - screening mammography and biopsy [two years]

    2. To validate and compare the diagnostic ability of the CDT for detection of breast cancer [two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah Medical Organization Jerusalem Israel 91120

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01043055
    Other Study ID Numbers:
    • 044809-HMO-CTIL
    First Posted:
    Jan 6, 2010
    Last Update Posted:
    Jan 6, 2010
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    Breast Cancer Screening
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jan 6, 2010