Malignant Breast Cancer, Benign Breast Lesions Clinical Trial
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.
| Verified date | December 2006 |
| Source | Ziv Hospital |
| Contact | Amram Hadari, MD |
| Phone | + 972 6828923 |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
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 "
| Status | Recruiting |
| Enrollment | 180 |
| Est. completion date | December 2010 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
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. |
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Israel | Surgery Department | Safed |
| Lead Sponsor | Collaborator |
|---|---|
| Ziv Hospital |
Israel,
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