NCT00581750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
13.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2021

Completed
Last Updated

July 2, 2021

Status Verified

June 1, 2021

Enrollment Period

19.8 years

First QC Date

December 21, 2007

Last Update Submit

June 30, 2021

Conditions

Breast CancerLobular CarcinomaInvasive Breast Cancer

Keywords

BiopsyBreast01-135

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Secondary Outcomes (4)

  • To perform analyses using microarray-based mRNA and microRNA gene expression profiling to identify distinct molecular subtypes within LCIS.

    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.

    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.

    2 years

  • To further characterize the invasive lobular breast cancers that develop in association with LCIS as assessed by standard histopathology and immunohistochemistry.

    2 years

Study Arms (1)

LCIS diagnosis

Patient with LCIS diagnosis

Other: Tissue specimen

Interventions

Tissue specimenOTHER

Human tissues taken after the clinically indicated removal of these tissues from patients as part of their routine care.

LCIS diagnosis

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women seen at MSKCC breast clinic

You may qualify if:

  • 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

You may not qualify if:

  • no paraffin blocks available
  • no residual lobular carcinoma in situ in paraffin blocks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Lobular

Interventions

Histocompatibility Testing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic Techniques

Study Officials

  • Melissa Pilewskie, M.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

October 1, 2001

Primary Completion

June 28, 2021

Study Completion

June 28, 2021

Last Updated

July 2, 2021

Record last verified: 2021-06

Locations

US(1)