title: Individualized five-year risk assessment for oral premalignant lesion progression to cancer.
abstract: OBJECTIVE
  The standard of care for premalignant lesion risk assessment is dysplasia grading by histopathology. With significant overlap between dysplasia grades and high inter- and intraobserver variations, histopathology dysplasia grading alone is not a useful prognostic tool. Our aim is to investigate whether a method for quantitatively assessing S100A7, a prognostic biomarker, using image analysis can better predict clinical outcome in cases with oral dysplasia.
  
  
  METHODS
  Using the Visiopharm image analysis system, we analyzed a cohort of 150 oral biopsy samples to build and test Straticyte, a model for individualized assessment of the 5-year risk of progression of oral precancerous lesions to invasive squamous cell carcinomas.
  
  
  RESULTS
  Straticyte classified lesions more accurately than histopathological dysplasia grading for risk to progression to cancer over the following 5 years. The sensitivity of low-risk versus intermediate- and high-risk Straticyte groups was 95% compared to 75% for mild versus moderate and severe dysplasia. Furthermore, the negative predictive value for low-risk versus intermediate- and high-risk Straticyte groups was 78% compared to 59% for mild versus moderate and severe dysplasia.
  
  
  CONCLUSIONS
  By quantitatively assessing S100A7, Straticyte better defines the risk for developing oral squamous cell carcinoma than histopathological dysplasia grading alone.
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada. Electronic address: Jhwang@proteocyte.com.
authors.forename: Jason T K
authors.initials: JT
authors.lastname: Hwang
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada.
authors.forename: Ying R
authors.initials: YR
authors.lastname: Gu
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada.
authors.forename: Mi
authors.initials: M
authors.lastname: Shen
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada; Alex and Simona Shnaider Research Laboratory in Molecular Oncology, Toronto, Ontario, Canada; Otolaryngology-Head and Neck Surgery, Sonshine Family Centre for Head and Neck Diseases, Toronto, Ontario, Canada; Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Ranju
authors.initials: R
authors.lastname: Ralhan
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada; Alex and Simona Shnaider Research Laboratory in Molecular Oncology, Toronto, Ontario, Canada; Otolaryngology-Head and Neck Surgery, Sonshine Family Centre for Head and Neck Diseases, Toronto, Ontario, Canada; Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada; Medicine, Endocrine Division, Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Walfish
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada; Laboratory Medicine and Pathobiology: Surgery, University of Toronto, Toronto, Ontario, Canada; Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.
authors.forename: Kenneth P H
authors.initials: KP
authors.lastname: Pritzker
authors.affiliation: Proteocyte Diagnostics Inc., Toronto, Ontario, Canada; Oral Pathology/Oral Medicine, Faculty of Dentistry, University of Toronto, Toronto, Ontario, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Mock
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001706:Biopsy; D002294:Carcinoma, Squamous Cell / Q000473:pathology*; D002471:Cell Transformation, Neoplastic / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000473:pathology*; D060787:Neoplasm Grading; D011230:Precancerous Conditions / Q000473:pathology*; D011237:Predictive Value of Tests; D018570:Risk Assessment