The Pap Smear Challenge: Comparing Clinical Performance of a Novel "Molecular Pap" Based on Next-Generation Sequencing to Traditional Cervical Cancer Screening
Abstract
The Molecular Pap is an integrated panel of biomarkers based on Human Papillomavirus (HPV) deep sequencing and quantitative DNA methylation of 3 human genes by pyrosequencing. To validate our biomarker panel and predictive model for Pap smear classification, we proposed to collect 700 Pap smear samples from each of 6 diagnostic categories for HPV genotyping and methylation quantification for direct comparison to traditional cervical cancer screening (cytology +/- cobas(registered trademark)HPV). Methods: This prospective, cross-sectional study uses residual liquid-based cytology samples for HPV genotyping and epigenetic analysis by pyrosequencing. A total of 3,037 Pap samples have been collected to date and have undergone various stages of DNA extraction, HPV DNA amplification, Sanger and deep sequencing, and bioinformatics analysis. Results: NA. Study is on-going. Accomplishments (Year 2): Pap sample collection has reached 80 percent of target accrual and molecular analyses are in-progress. Six contracts for supplies, software, cloud-based bioinformatics, and taxonomic profiling have been awarded. The development of a real-world, automated, data science pipeline for multiple types of genomics data has been initiated.
Document Details
- Document Type
- Technical Report
- Publication Date
- Apr 01, 2019
- Accession Number
- AD1094124
Entities
People
- Jane Shen-Gunther