Clinical Sensitivity Verification Study of Circulating Tumor Cells Gene Mutation Detection From Advanced NSCLC Patients

Overview

Verify the Coincidence rate between Circulating tumor cells (CTCs) and tumor tissue or Circulating tumor DNA (ctDNA) of advanced NSCLC patients with Driver gene mutation

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 15, 2020

Detailed Description

1. Enrich CTCs from advanced Non-Small Cell Lung Cancer (NSCLC) patients with Driver gene mutation, and detect the Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic lymphoma kinase (ALK) fusion, ROS proto-oncogene receptor tyrosine kinase 1 (ROS1) fusion, RET proto-oncogene (RET) fusion and Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping by Lung cancer Polymerase Chain Reaction (PCR) panel kit, and verify the mutation coincidence rate between CTCs and tumor tissue. 2. Enrich ctDNA from advanced NSCLC patients with Driver gene mutation, detect the EGFR mutation by PCR, and detect the ALK fusion, ROS1 fusion, RET fusion and MET 14 exon skipping by next generation sequencing (NGS), and compare the mutation coincidence rate between CTCs and ctDNA.

Interventions

  • Other: nonintervention
    • nonintervention

Arms, Groups and Cohorts

  • Driver gene mutation-positive
    • Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation positive.
  • Driver gene mutation-negative
    • Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a Driver gene mutation negative.

Clinical Trial Outcome Measures

Primary Measures

  • Driver gene mutation frequency from CTCs of advanced NSCLC patients
    • Time Frame: 6 months
    • Analyze the driver gene mutation frequency in CTCs from advanced NSCLC patients with tumor tissue driver gene mutation
  • The gene mutation coincidence rate between CTCs and tumor tissue sample
    • Time Frame: 6 months
    • Comparison the gene mutation coincidence rate between CTCs and tumor tissue sample

Secondary Measures

  • Driver gene mutation frequency from ctDNA of advanced NSCLC patients
    • Time Frame: 6 months
    • Analyze the driver gene mutation frequency in ctDNA from advanced NSCLC patients with tumor tissue driver gene mutation
  • The gene mutation coincidence rate between CTCs and ctDNA
    • Time Frame: 6 months
    • Comparison the gene mutation coincidence rate between CTCs and ctDNA

Participating in This Clinical Trial

Inclusion Criteria

1. Female or male, 18 years of age or older 2. Histologically or cytologically proven diagnosis of advanced NSCLC patients without any target therapy or chemotherapy 3. Able to get tumor tissue gene (EGFR/ALK/ROS1/RET/MET skipping) testing results by Lung cancer Polymerase Chain Reaction (PCR) panel kit carried out in hospital 4. Signed and dated informed consent Exclusion Criteria:

1. Combine with other tumor type 2. The investigator judges the situation that may affect the clinical search process and results

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Pulmonary Hospital, Shanghai, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Caicun Zhou, Director Head of Medical Oncology – Shanghai Pulmonary Hospital, Shanghai, China
  • Overall Official(s)
    • Yayi He, MD,PHD, Principal Investigator, Shanghai Pulmonary Hospital, Tongji University
  • Overall Contact(s)
    • Yayi He, MD,PHD, +862165115006, 2250601@qq.com

References

Haber DA, Velculescu VE. Blood-based analyses of cancer: circulating tumor cells and circulating tumor DNA. Cancer Discov. 2014 Jun;4(6):650-61. doi: 10.1158/2159-8290.CD-13-1014. Epub 2014 May 6.

Li Y, Xu H, Su S, Ye J, Chen J, Jin X, Lin Q, Zhang D, Ye C, Chen C. Clinical validation of a highly sensitive assay to detect EGFR mutations in plasma cell-free DNA from patients with advanced lung adenocarcinoma. PLoS One. 2017 Aug 22;12(8):e0183331. doi: 10.1371/journal.pone.0183331. eCollection 2017. Erratum In: PLoS One. 2017 Dec 7;12 (12 ):e0189549.

Krebs MG, Metcalf RL, Carter L, Brady G, Blackhall FH, Dive C. Molecular analysis of circulating tumour cells-biology and biomarkers. Nat Rev Clin Oncol. 2014 Mar;11(3):129-44. doi: 10.1038/nrclinonc.2013.253. Epub 2014 Jan 21.

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