Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional 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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|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|
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
Option of keeping tissue sample for further research
|Study Start Date:||November 2004|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146536
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Faina Nakhlis, MD||Dana-Farber Cancer Institute|