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

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 Overview

• Status: Unknown
• Conditions: Circulating Tumor DNA; Advanced NSCLC; Circulating Tumor Cells
• Intervention / Treatment: Other: nonintervention

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Yayi He, MD,PHD; Phone Number: +862165115006; Email: 2250601@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Histologially or cytologically proven diagnosis of advanced NSCLC

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: nonintervention; nonintervention
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.	Other: nonintervention; nonintervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Yayi He, MD,PHD, Shanghai Pulmonary Hospital, Tongji University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2020
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): December 15, 2020

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasm Metastasis; Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: CTC-FM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No