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

Circulating Tumor DNA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04229121
• Other study ID #: CTC-FM
• Status: Not yet recruiting
• Start date: January 15, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: January 2020
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yayi He, MD,PHD
• Phone: +862165115006
• Email: 2250601[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced NSCLC
• Circulating Tumor Cells
• Circulating Tumor DNA
• Neoplasms
• Neoplastic Cells, Circulating

Intervention

Other:
• nonintervention
nonintervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

References & Publications (3)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	The gene mutation coincidence rate between CTCs and ctDNA	Comparison the gene mutation coincidence rate between CTCs and ctDNA	6 months