Advanced NSCLC, Circulating Tumor Cells, Circulating Tumor DNA
Conditions
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.
Interventions
OTHERnonintervention
nonintervention
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The gene mutation coincidence rate between CTCs and ctDNA | 6 months | Comparison the gene mutation coincidence rate between CTCs and ctDNA |
Contacts
Primary ContactYayi He, MD,PHD
Outcome results
None listed