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Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy

This study has been completed.
Sponsor:
Collaborators:
Translational Breast Cancer Research Consortium
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Faina Nakhlis, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00146536
First received: September 2, 2005
Last updated: November 29, 2012
Last verified: November 2012
History of Changes

September 2, 2005
November 29, 2012
November 2004
November 2012   (final data collection date for primary outcome measure)
Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy [ Time Frame: Concomittant ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00146536 on ClinicalTrials.gov Archive Site
Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy
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

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Option of keeping tissue sample for further research
Non-Probability Sample

Individuals who have ALH/LCIS detected on a needle biospy of the breast
Breast Neoplasms
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women 20 years of age or older
  • Imaging abnormality necessitating a core needle biopsy
  • Core needle biopsy revealing ALH or LCIS
  • Patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia

Exclusion Criteria:

  • History and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS)
  • A palpable abnormality diagnosed by core needle biopsy to be ALH or LCIS
  • Received tamoxifen in the past
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00146536
04-164
No
Faina Nakhlis, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Translational Breast Cancer Research Consortium
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
Principal Investigator: Faina Nakhlis, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP