We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

Using Test of SCM for Detection Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Ziv Hospital.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: December 5, 2006
Last Update Posted: December 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ziv Hospital

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:

Further study details as provided by Ziv Hospital:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407706

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

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
Principal Investigator: Amram Hadari, MD Surgery Department
  More Information


ClinicalTrials.gov Identifier: NCT00407706     History of Changes
Other Study ID Numbers: HP 6-218 S
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: December 5, 2006
Last Verified: December 2006

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

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