Using Test of SCM for Detection Breast Cancer

December 4, 2006 updated by: Ziv Hospital

Breast Cancer- Early Detection of Cancer Disease and Pre-Cancer Disease, and in Women That Are at High Risk for Developing Breast Cancer by Identifying Lymphocytes Previously Exposed to Specific Cancer Antigen.

In our previous research, we have shown that women that have breast cancer have a population of lymphocytes that recognizes specific antigen and there cytoplasmic matrix goes through physical change a short time after exposure in vitro to the same antigen. This change can be measured by polarization changes of fluorescent light emitted by FDA (fluorescein diacetate) labeled cells. Further test that we performed showed that those differences are also shown in a benign situation that known as indicator for a high risk for developing breast cancer within 10-15 years. The incidence of the expression of these lymphocytes correlates with the histopathological picture as it is related in high risk for the developing the disease.

In this work we will expand the scope of the procedure to early detection of the cancerous process in breast lesions by Fitzgibbon's risk categories for the development invasive carcinoma of the breast. In the proposed work we intend to use specific antigen MUC1 for breast cancer. This study is a continuation of our published work in the "The Breast "

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Safed, Israel, 13110
        • Recruiting
        • Surgery department
        • Contact:
          • Amram Hadari, MD
          • Phone Number: + 972 4 6828923
        • Contact:
          • Tali Keren, MA
          • Phone Number: + 972 4 682 8828
        • Principal Investigator:
          • Amram Hadari, MD
        • Sub-Investigator:
          • Tali Keren, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women carrying benign breast lesions will be further divided and analyzed according to the Fitzgibbon's risk categories for invasive cancer risk (4). The Fitzgibbon's categories are:

  1. No increased risk group including adenosis (other than sclerotic), duct ectasia fibroadenoma without complex features,
  2. slightly increased risk group (1.5-20 times) which includes fibroadenoma with complex features, moderate or florid hyperplasia without atypia, sclerosing adenosis,
  3. moderately increased risk group (4.0-5.0 times) includes atypical ductal and lobular hyperplasia and
  4. markedly increased risk group (8.0-10.0 times) which includes ductal and lobular carcinomas In Situ Following the blood collection, detailed relevant clinical information of the patient will be registered in a case record form.

The data will include: age, country of birth, last menstrual period, lactation, number of children, age at first full-term pregnancy, age at onset of menopause, family history, medication, mammography findings, FNA results, tumor size, histological findings, biopsies, disease staging, and other relevant clinical information.

Exclusion Criteria:

  1. pregnancy,
  2. experiencing menstruation, or
  3. under hormonal or drug treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: Amram Hadari, MD, Surgery department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion

December 1, 2010

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2006

Last Update Submitted That Met QC Criteria

December 4, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP 6-218 S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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