Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With

Status Completed

Clinical Trial Summary

This study is being done in order to better understand the biology of an abnormal lesion found in breast tissue called "lobular carcinoma in situ" (LCIS). We are interested in studying LCIS. The LCIS is not a cancer itself, but is a marker for an increased risk of cancer. We would like to look for LCIS in breast tissue removed during surgery from patients with cancer or at high risk for cancer. If LCIS is found, we will search for genes that are expressed (turned on or off) differently than in normal breast tissue. The identification of such genes would help us better understand the biology of LCIS, and its possible relationship to breast cancer.

Clinical Trial Description

LCIS) is a monoclonal pathologic entity which is subject to characterization at the molecular genetic level, and that these molecular genetic alterations may be used to predict the subsequent development of invasive breast cancer. Prophylactic mastectomy specimens from women with multifocal LCIS, and invasive breast cancer specimens which display coexisting LCIS, will be examined for X-chromosome inactivation patterns and loss of heterozygosity to assess for monoclonality. If clonality is present, we will assess for microsatellite instability, and a microarray-based comparative genomic hybridization (CGH) technique will be used to identify genetic alterations present in LCIS. Lastly, LCIS biopsy specimens from untreated patients who, after follow-up did or did not develop invasive breast cancer, will be evaluated to determine whether the nature or extent of any identified genetic alterations can be correlated with the subsequent development of invasive breast cancer. We hypothesize that a fraction of LCIS lesions will reflect a monoclonal origin, that those lesions of monoclonal origin will display evidence of specific molecular genetic alterations, and that these specific alterations will correlate with the likelihood of the subsequent development of invasive breast carcinoma. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00581750
Study type	Observational
Source	Memorial Sloan Kettering Cancer Center
Contact
Status	Completed
Phase
Start date	October 2001
Completion date	June 28, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms