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Using Test of SCM for Detection Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Ziv Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT00407706
First received: December 4, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 "


Condition Intervention
Malignant Breast Cancer, Benign Breast Lesions
 Procedure: blood test

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Estimated Enrollment: 180
Study Start Date: December 2006
Estimated Study Completion Date: December 2010
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407706

Contacts
Contact: Amram Hadari, MD + 972 6828923
Contact: Tali Keren, MA +972 4 6828828 tali.k@ziv.health.gov.il

Locations
Israel
Surgery Department Recruiting
Safed, Israel, 13110
Contact: Amram Hadari, MD     + 972 4 6828923        
Contact: Tali Keren, MA     + 972 4 682 8828        
Principal Investigator: Amram Hadari, MD            
Sub-Investigator: Tali Keren, MA            
Sponsors and Collaborators
Ziv Hospital
Investigators
Principal Investigator: Amram Hadari, MD Surgery Department
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00407706     History of Changes
Other Study ID Numbers: HP 6-218 S
Study First Received: December 4, 2006
Last Updated: December 4, 2006
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
Breast Cancer, FACS, SCM, Malignant, Benign, Lymphocytes

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

ClinicalTrials.gov processed this record on May 16, 2013