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Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, March 2009
First Received: December 21, 2007   Last Updated: March 11, 2009   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
Anderson Cancer Institute/ Memorial Health University Medical Center, Savannah, Georgia
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00581750
  Purpose

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
Breast Cancer
Lobular Carcinoma
Invasive Breast Cancer
Other: Tissue specimen

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine whether multifocal LCIS is a monoclonal phenomenon by assessing X-chromosome inactivation patterns and loss of heterozygosity at polymorphic markers in prophylactic mastectomy specimens from women with multifocal LCIS. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess for the presence of microsatellite instability in LCIS lesions which show evidence of monoclonality. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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
LCIS diagnosis
Patient with LCIS diagnosis
Other: Tissue specimen
Human tissues taken after the clinically indicated removal of these tissues from patients as part of their routine care.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women seen at MSKCC breast clinic

Criteria

Inclusion Criteria:

  • multifocal lobular carcinoma in situ treated with prophylactic mastectomy
  • invasive breast cancer (lobular or ductal) with coexisting lobular carcinoma in situ treated with mastectomy
  • biopsy proven, untreated lobular carcinoma in situ
  • invasive lobular cancer with or without coexisting lobular carcinoma in situ treated with mastectomy or lumpectomy

Exclusion Criteria:

  • no paraffin blocks available
  • no residual lobular carcinoma in situ in paraffin blocks
  • previous or current use of tamoxifen for lobular carcinoma in situ
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581750

Contacts
Contact: Tari King, M.D. kingt@mskcc.org

Locations
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.            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Anderson Cancer Institute/ Memorial Health University Medical Center, Savannah, Georgia
Investigators
Principal Investigator: Tari King, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Biopsy
Breast

Study placed in the following topic categories:
Carcinoma, Lobular
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009