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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Anderson Cancer Institute/ Memorial Health University Medical Center, Savannah, Georgia |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00581750 |
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.
Condition | Intervention |
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Breast Cancer Lobular Carcinoma Invasive Breast Cancer |
Other: Tissue specimen |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ |
Tissue
Estimated Enrollment: | 80 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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LCIS diagnosis
Patient with LCIS diagnosis
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Other: Tissue specimen
Human tissues taken after the clinically indicated removal of these tissues from patients as part of their routine care.
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women seen at MSKCC breast clinic
Inclusion Criteria:
Exclusion Criteria:
Contact: Tari King, M.D. | kingt@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Tari King, M.D. kingt@mskcc.org | |
Contact: Monica Morrow, MD morrowm@mskcc.org | |
Principal Investigator: Tari King, M.D. |
Principal Investigator: | Tari King, M.D. | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Tari King, M.D. ) |
Study ID Numbers: | 01-135 |
Study First Received: | December 21, 2007 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00581750 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Biopsy Breast |
Carcinoma, Lobular Skin Diseases Carcinoma in Situ Breast Neoplasms |
Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Carcinoma, Lobular Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Carcinoma in Situ |
Breast Neoplasms Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |