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Methods of subclassification of ductal carcinoma in situ of the breast 
Patent Number: US8999647

Executive Summary:
  • Invention Type: Diagnostic
  • Patent Status: Issued (Grant date: 2015-04-07)
  • Patent Link: https://patents.google.com/patent/US8999647/
  • Research Institute: Duke University
  • Disease Focus: Ductal carcinoma
  • Basis of Invention: Standard pathologic evaluation does not distinguish DCIS lesions with or without the capacity to progress. In addition, no molecular changes have been identified that reliably differentiate indolent from aggressive DCIS
  • How it works: expression profile of certain genes will determine indolent from aggressive DCIS
  • Lead Challenge Inventor: Joseph Geradts
  • Inventors: Geradts; Joseph (Chapel Hill, NC)
  • Development Stage: in vitro human samples
  • Novelty: potential novel method of differentiating indolent from aggressive DCIS
  • Clinical Applications: Pathologic evaluation

General Description:
Ductal carcinomas in situ (DCIS) accounts for about 20% of newly diagnosed breast cancers in the United States amounting to nearly 40,000 cases per year. Standard pathologic evaluation does not distinguish DCIS lesions with or without the capacity to progress. In addition, no molecular changes have been identified that reliably differentiate indolent from aggressive DCIS. As there are no distinguishing features of indolent DCIS, the great majority of patients tend to be over-treated. Patients with a diagnosis of DCIS receive additional surgery, radiation or systemic therapy. Such aggressive treatments are not necessary in 80-90% of LG DCIS and in 50-70% of HG DCIS cases. Investigators at Duke University, have come up with a method of determining the aggressiveness or indolence of a ductal carcinoma in situ lesion.

Strengths:
  • No molecular-based classification has yet been developed

Weaknesses:
  • Has been tested on very few patients

Patent Status:
  • Priority date:  2009-03-09
  • Filing date:  2009-12-11
  • Publication date: 2015-04-07
  • Grant date: 2015-04-07

Inventor Bio: Joseph Geradts
https://scholars.duke.edu/person/joseph.geradts
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