Validation of a Gene Expression Test for Mesothelioma Prognosis in Formalin-Fixed Paraffin-Embedded Tissues

Details

• Personal Author:
  Amin W ; Becich MJ ; Bueno R ; Cook RW ; De Rienzo A ; Feldman MD ; Gustafson CE ; Johnson CE ; Maetzold DJ ; Oelschlager KM ; Richards WG ; Stone JF ; Wilkinson J ; Yeap BY
• Description:
  A molecular test performed using fresh-frozen tissue was proposed for use in the prognosis of patients with pleural mesothelioma. The accuracy of the test and its properties was assessed under Clinical Laboratory Improvement Amendments-approved guidelines using FFPE tissue from an independent multicenter patient cohort. Concordance studies were performed using matched frozen and FFPE mesothelioma samples. The prognostic value of the test was evaluated in an independent validation cohort of 73 mesothelioma patients who underwent surgical resection. FFPE-based classification demonstrated overall high concordance (83%) with the matched frozen specimens, on removal of cases with low confidence scores, showing sensitivity and specificity in predicting type B classification (poor outcome) of 43% and 98%, respectively. Concordance between research and clinical methods increased to 87% on removal of low confidence cases. Median survival times in the validation cohort were 18 and 7 months in type A and type B cases, respectively (P = 0.002). Multivariate classification adding pathologic staging information to the gene expression score resulted in significant stratification of risk groups. The median survival times were 52 and 14 months in the low-risk (class 1) and intermediate-risk (class 2) groups, respectively. The prognostic molecular test for mesothelioma can be performed on FFPE tissues to predict survival, and can provide an orthogonal tool, in combination with established pathologic parameters, for risk evaluation. [Description provided by NIOSH]
• Subjects:
  Diagnosis Genetics Laboratories Neoplasms Occupational Health Pathology Respiratory Tract Diseases Risk Assessment Safety
• Keywords:
  Clinical Pathology Clinical Tests Diagnostic Tests Gene Expression Genes Humans Laboratory Testing Medical Screening Mesothelioma Molecular Signaling Pulmonary-system-disorders Respiratory-system-disorders Risk Analysis Survival Rate Tissue Culture

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• ISSN:
  1525-1578
• Document Type:
  Text
• Funding:
  Cooperative Agreement
• Genre:
  Journal Article
• Place as Subject:
  Arizona ; Massachusetts ; OSHA Region 1 ; OSHA Region 3 ; OSHA Region 6 ; OSHA Region 9 ; Pennsylvania ; Texas
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  65-71
• Volume:
  19
• Issue:
  1
• NIOSHTIC Number:
  nn:20050134
• Citation:
  J Mol Diagn 2017 Jan; 19(1):65-71
• Contact Point Address:
  Raphael Bueno, M.D., Division of Thoracic Surgery, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115
• Email:
  rbueno@partners.org
• Federal Fiscal Year:
  2017
• NORA Priority Area:
  Construction ; Manufacturing
• Performing Organization:
  University of Pittsburgh at Pittsburgh
• Peer Reviewed:
  True
• Start Date:
  20060901
• Source Full Name:
  The Journal of Molecular Diagnostics
• End Date:
  20260831
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:2ca4f63e459bc63ccfe91399f41736b16e67a884129d4f316d1279aa2d445c107cdc9792420e8422d533402e8b1103aa10b9a1a0e8fa9dcb7da43434459c3af4
• Download URL:
  https://stacks.cdc.gov/view/cdc/210614/cdc_210614_DS1.pdf
• File Type:
  [PDF - 564.18 KB ]