LTP2 Results Analysis-Willey-Toledo-2024

Abbreviated Name
LTP2 Results Analysis-Willey-Toledo-2024
Lead Investigator
Willey, JamesUniversity of Toledo College of Medicine
Coordinating Investigator
Zheng, Yingye Fred Hutchinson Cancer Center
Involved Investigators

Abstract

No abstract availalbe.

Aims

See analysis plan.

Analytic Method

The planned targeted NGS method enables measurement of TP53/PIK3CA/BRAF variants with VAF as low as 0.0005 (0.05%). In this proposed project, we will assess accuracy of the LFAMB by receiver operator characteristic (ROC) area under the curve (AUC) to identify the cut-off with best positive likelihood ratio for identification of those at high risk for lung cancer diagnosis. The LFAMB is measured as mutation prevalence in units of mutations/base position assessed, mutations/bp. For power analysis, based on preliminary data from the case-control study reported in Craig et al (2019)28 we will test the hypothesis that a cut-off threshold of 0.02 mutations/bp in AEC DNA will identify cancer subjects with >95% specificity and 55% sensitivity, using a two-tailed test for significance and a type-1 error rate of 0.05. We will assume based on preliminary data that the fraction of the study population with a positive biomarker is 32%. Based on these assumptions, analysis of specimens from 60 subjects will have 80% power to test the 0.02 mutations/bp cut-off for 95% specificity and 55% sensitivity, which is associated with a positive likelihood ratio of 11.

Publications

  • No publications available at this time for this protocol.

Biomarkers

  • No biomarkers available at this time for this protocol.

Data Collections

  • No data collections available at this time for this protocol.
Protocol ID
555
Protocol Type
Reference Set
Fields of Research
  • UNKNOWN
Collaborative Group
Lung and Upper Aerodigestive Cancers Research Group
Cancer Types
  • Malignant neoplasm of bronchus and lung

Associated Forms