Author of

• 31322

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  P2.11 - Screening and Early Detection (ID 178)

  • Event: WCLC 2019
  • Type: Poster Viewing in the Exhibit Hall
  • Track: Screening and Early Detection
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall

  • 31357

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    P2.11-29 - Diagnosis and Surveillance of Solitary Pulmonary Nodules with ctDNA Methylation Sequencing: Protocol for a Prospective Multicenter Study (ID 1666)

    10:15 - 18:15  |  Author(s): Jianbing Fan
    • Abstract

    Background
    

    LDCT screening can identify early-stage lung cancers yet introduces excessive false positives , which calls for better non-invasive diagnostic tools. We previously established a diagnostic model of early stage lung cancer based on high-throughput DNA methylation sequencing of ctDNA (Theranostics 2019; 9(7)). The aim of the present study is to assess the role of ctDNA methylation markers in differential diagnosis and surveillance of pulmonary nodules.

    Method
    

    A prospective cohort of 10,560 patients from 20 centers in China with non-calcified nodules range from 0.5 to 3 cm in diameter indicated by LDCT or CT will be included and followed up for 2 to 3 years. Each patient will undergo LDCT/CT follow-up and their information as well as blood sample will be collected at baseline, 3, 6, 12, 24 and 36 months. Blood samples will be subjected to ctDNA methylation test. Sensitivity, specificity, positive predictive value and negative predictive value are used to measure the diagnostic value of ctDNA methylation test in differentiating benign and malignant pulmonary nodules.

    Result
    

    This study is registered in clinicaltrials.gov (NCT03651986, BELL study) and has launched since Oct 2018. Upon submission, 975 cases had been enrolled from 13 centers who had begun recruiment. Completion of data collection is anticipated by March 2023.

    Conclusion
    

    To the best of our knowledge, this is the first and largest study worldwide to test the efficacy of ctDNA methylation markers in differential diagnosis and surveillance of pulmonary nodules.