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

• Conditions: Advanced NSCLC; Circulating Tumor Cells; Circulating Tumor DNA
• Interventions: Other: nonintervention

• Registration Number: NCT04229121
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study Start: 2020-01-15
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-06-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Driver gene mutation-negative	nonintervention	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.
Driver gene mutation-positive	nonintervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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