Viewing Study NCT00146536



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00146536
Status: COMPLETED
Last Update Posted: 2017-03-31
First Post: 2005-09-02

Brief Title: Upstaging of ALHLCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy
Sponsor: Dana-Farber Cancer Institute
Organization: Dana-Farber Cancer Institute

Study Overview

Official Title: The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma DCIS or Atypical Ductal Hyperplasia ADH in Patients Diagnosed With Lobular Neoplasia of the Breast by Core Needle Biopsy
Status: COMPLETED
Status Verified Date: 2012-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this study is to determine how often patients who have atypical lobular hyperplasia ALH or lobular carcinoma in situ LCIS on core needle biopsy of an imaging found by mammogram or breast ultrasound abnormality will have associated breast cancer at surgical removal of the area
Detailed Description: Patients will undergo a breast biopsy at which the area found to be ALH or LCIS on core biopsy will be removed surgically through a small incision in the breast

The surgical biopsy specimen will be carefully examined by a pathologist and may be useful in guiding further therapy if needed
In the future tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention The tissue will be kept for future research for up to 10 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None