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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.


N/A
18 Years
50 Years
Open (Enrolling)
Female
Malignant Breast Cancer, Benign Breast Lesions

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Trial Information

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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional, Time Perspective: Prospective

Principal Investigator

Amram Hadari, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Surgery Department

Authority:

Israel: Ministry of Health

Study ID:

HP 6-218 S

NCT ID:

NCT00407706

Start Date:

December 2006

Completion Date:

December 2010

Related Keywords:

  • Malignant Breast Cancer, Benign Breast Lesions
  • Breast Cancer, FACS, SCM, Malignant, Benign, Lymphocytes
  • Breast Neoplasms

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