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

June 30, 2021 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women seen at MSKCC breast clinic

Description

Inclusion Criteria:

  • multifocal lobular carcinoma in situ treated with prophylactic mastectomy or lumpectomy
  • invasive breast cancer (lobular or ductal) with coexisting lobular carcinoma in situ treated with mastectomy or lumpectomy
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To perform analyses using microarray-based gene expression profiling to determine whether a unique mRNA and microRNA gene expression profile distinguishes LCIS from normal breast epithelium and from invasive carcinoma.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To perform analyses using microarray-based mRNA and microRNA gene expression profiling to identify distinct molecular subtypes within LCIS.
Time Frame: 2 years
2 years
Deter the nature or extent of molecular genetic alterations in LCIS as asses by mRNA & microRNA microarray canbe correl with the risk of subsequent invas breast cancer in pts with class type LCIS & those with newly described histologic variants of LCIS.
Time Frame: 2 years
2 years
To prospectively follow patients diagnosed with newly described histologic variants of lobular carcinoma in situ, who do or do not undergo surgery for treatment or prevention, to better characterize this lesion and its behavior.
Time Frame: 2 years
2 years
To further characterize the invasive lobular breast cancers that develop in association with LCIS as assessed by standard histopathology and immunohistochemistry.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Melissa Pilewskie, M.D., Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

June 28, 2021

Study Completion (Actual)

June 28, 2021

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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