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• 20183

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  P3.04 - Clinical Design, Statistics and Clinical Trials (ID 720)

  • Event: WCLC 2017
  • Type: Poster Session with Presenters Present
  • Track: Clinical Design, Statistics and Clinical Trials
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)

  • 24077

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    P3.04-001 - Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer  (ID 9541)

    09:30 - 09:30  |  Author(s): R. Yung
    • Abstract
    • Slides

    Background:
    This Study will assess the stability of the ProLung China Test classification algorithm when used as an adjunct to CT scan. Also, we will assess whether there are any potential safety concerns of the ProLung China Test when used to evaluate patients with a positive CT scan for lung cancer.
    
    Method:
    This study is a multicentre, prospective, open, self-control study which aims to evaluate the utility of the ProLung China Test in diagnosis of lung cancer (ClinicalTrials.gov ID: NCT02726633 ). The subject whose age is between 18 and 80 years old and CT result shows a 4 ~ 50 mm nodule within 30 days is our object. In these objects, we will exclude those people who has TB, pulmonary edema, chronic lung infection, abnormal anatomy, skin disease effecting bioconductance and other tumors.The expected sensitivity and specificity of Prolung China Test are 70 % and 61%, and non-inferiority margin is 10 %. Based on these statistical information, four clinical trial centers, in the study, will enroll at least 452 samples with 20 % dropout rate. These samples must contain at least 182 effective malignant sample and 194 benign samples.
    
    Result:
    According to the inclusion and exclusion criteria, excision biopsy or follow-up examination will perform on enrolled subjects. Before these examination, a Prolung China test will be operated on these subjects. The subject in follow-up will be followed at least 24 months. The pathology result and follow-up result will be the gold standard in this study. The diagnosis result and adverse event will be recorded during the experiment.
    
    Conclusion:
    To demonstrate safety and efficacy of the ProLung China Test in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.
    
    

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