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

December 4, 2006
December 4, 2006
December 2006
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No Changes Posted
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Using Test of SCM for Detection Breast Cancer
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 "

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Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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Malignant Breast Cancer, Benign Breast Lesions
Procedure: blood test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
December 2010
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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.
Female
18 Years to 50 Years
No
Contact: Amram Hadari, MD + 972 6828923
Contact: Tali Keren, MA +972 4 6828828 tali.k@ziv.health.gov.il
Israel
 
NCT00407706
HP 6-218 S
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Ziv Hospital
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Principal Investigator: Amram Hadari, MD Surgery Department
Ziv Hospital
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP