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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01043055
First received: January 5, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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


Condition
Breast Cancer

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Blood


Estimated Enrollment: 140
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)
Groups/Cohorts
Breast Cancer Patients
Healthy Control Group

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
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Breast cancer patients over age 40 before treatment. Healthy women recruited in Check Up institute from asymptomatic women over age 40, referred to screening mammography and received the negative result of mammography.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043055

Contacts
Contact: Tamar Peretz, MD 6777825 ext 009722 tamary@hadassah.org.il
Contact: Hadas Lemberg, PhD 6777572 ext 009722 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DmD     6776095 ext 009722     arik@hadassah.org.il    
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            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Tamar Peretz, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Prof. Tamar Peretz, Head of Oncology Department, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01043055     History of Changes
Other Study ID Numbers: 044809-HMO-CTIL
Study First Received: January 5, 2010
Last Updated: January 5, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Breast Cancer Screening

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013