Upstaging of ALH/LCIS Found on Core Biopsy Based on Subsequent Excisional Biopsy
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|ClinicalTrials.gov Identifier: NCT00146536|
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : March 31, 2017
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||78 participants|
|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|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
- Rate of upstaging from Lobular Neoplasia on core biopsy to invasive breast cancer or ductal carcinoma in situ on excisional biopsy [ Time Frame: Concomittant ]
- Factors which predict for upstaging from Lobular Neoplasia on core biopsy to invasive breast carcinoma or ductal carcinoma in situ
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146536
|United States, Massachusetts|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Faina Nakhlis, MD||Dana-Farber Cancer Institute|