Clinical trial NCT00407706: Using Test of SCM for Detection Breast Cancer
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Breast Cancer, Benign Breast Lesions
Keywords: Breast Cancer, FACS, SCM, Malignant, Benign, Lymphocytes
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2006-12-05
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: 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 "


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Surgery Department
Study officials:
affiliation: Surgery Department
name: Amram Hadari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klein O, Lin S, Embon O, Sazbon A, Zidan J, Kook AI. An approach for high sensitivity detection of prostate cancer by analysis of changes in structuredness of the cytoplasmic matrix of lymphocytes specifically induced by PSA-ACT. J Urol. 1999 Jun;161(6):1994-6.
citation: Klein O, Linn S, Hadari A, Davidson C, Eitan A, Zidan J, Kook AI. An approach for high sensitivity detection of breast cancer by analysis of changes in structure of the cytoplasmic matrix of lymphocytes specifically induced by a specific breast tumour antigen (MUC-l/SEC). Breast. 2002 Apr;11(2):137-43. doi: 10.1054/brst.2001.0315.
citation: Fitzgibbons PL, Henson DE, Hutter RV. Benign breast changes and the risk for subsequent breast cancer: an update of the 1985 consensus statement. Cancer Committee of the College of American Pathologists. Arch Pathol Lab Med. 1998 Dec;122(12):1053-5.
citation: Smorodinsky N, Weiss M, Hartmann ML, Baruch A, Harness E, Yaakobovitz M, Keydar I, Wreschner DH. Detection of a secreted MUC1/SEC protein by MUC1 isoform specific monoclonal antibodies. Biochem Biophys Res Commun. 1996 Nov 1;228(1):115-21. doi: 10.1006/bbrc.1996.1625.
citation: Karanikas V, Hwang LA, Pearson J, Ong CS, Apostolopoulos V, Vaughan H, Xing PX, Jamieson G, Pietersz G, Tait B, Broadbent R, Thynne G, McKenzie IF. Antibody and T cell responses of patients with adenocarcinoma immunized with mannan-MUC1 fusion protein. J Clin Invest. 1997 Dec 1;100(11):2783-92. doi: 10.1172/JCI119825.
citation: Hiltbold EM, Ciborowski P, Finn OJ. Naturally processed class II epitope from the tumor antigen MUC1 primes human CD4+ T cells. Cancer Res. 1998 Nov 15;58(22):5066-70.
citation: Kelly JM, Darcy PK, Markby JL, Godfrey DI, Takeda K, Yagita H, Smyth MJ. Induction of tumor-specific T cell memory by NK cell-mediated tumor rejection. Nat Immunol. 2002 Jan;3(1):83-90. doi: 10.1038/ni746. Epub 2001 Dec 17.
citation: Klein O, Linn S, Davidson C, Hadary A, Shukha A, Zidan J, Eitan A, Kook AI. Early detection of malignant process in benign lesions of breast tumor by measurements of changes in structuredness of cytoplasmic matrix in circulating lymphocytes (SCM test) reinduced in vitro by specific tumor antigen. Breast. 2002 Dec;11(6):478-83. doi: 10.1054/brst.2002.0477.