Using Test of SCM for Detection Breast Cancer

NCT00407706 | Unknown

• 1 other identifier: HP 6-218 S
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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 "

Conditions

Malignant Breast Cancer, Benign Breast Lesions

Keywords

Breast Cancer, FACS, SCM, Malignant, Benign, Lymphocytes

Interventions

blood test PROCEDURE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• No increased risk group including adenosis (other than sclerotic), duct ectasia fibroadenoma without complex features,
• slightly increased risk group (1.5-20 times) which includes fibroadenoma with complex features, moderate or florid hyperplasia without atypia, sclerosing adenosis,
• moderately increased risk group (4.0-5.0 times) includes atypical ductal and lobular hyperplasia and
• 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.

You may not qualify if:

• pregnancy,
• experiencing menstruation, or
• under hormonal or drug treatment.

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Surgery Department

Safed, 13110, Israel

RECRUITING

Related Publications (8)

• 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.

  PMID: 10332488 BACKGROUND

• 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.

  PMID: 14965660 BACKGROUND

• 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.

  PMID: 9870852 BACKGROUND

• 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.

  PMID: 8912645 BACKGROUND

• 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.

  PMID: 9389743 BACKGROUND

• 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.

  PMID: 9823312 BACKGROUND

• 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.

  PMID: 11743585 BACKGROUND

• 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.

  PMID: 14965713 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Amram Hadari, MD

  Surgery Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amram Hadari, MD

CONTACT

+ 972 6828923

Tali Keren, MA

CONTACT

+972 4 6828828; tali.k@ziv.health.gov.il

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: December 1, 2006
• Study Completion: December 1, 2010
• Last Updated: December 5, 2006

Record last verified: 2006-12

Locations

IL (1)