ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS

Non-small Cell Lung Cancer Stage I Clinical Trial

Official title:

Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03172156
• Other study ID #: GASTO1018
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2017
• Last updated: October 9, 2017
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2017
• Source: Sun Yat-sen University
• Contact: Si-Yu Wang, MD
• Phone: 86-20-87343439
• Email: wsysums[@]163.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

CtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .

Description:

CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postoperative histopathological diagnosis of TNM stage IA / IB NSCLC with R0 resection;

• No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;

General selection criteria:

• Men or women of age =18 years and <75 years old;

• ECOG behavior status score 0 to 1;

Exclusion Criteria:

• Patients with other cancers other than NSCLC within five years prior to this study;

• who can not get enough tumor histological specimens (non-cytological) for analysis;

• human immunodeficiency virus (HIV) infection;

• NSCLC mixed with patients with small cell lung cancer;

• pregnant or lactating women;

• There is a clear history of neurological or mental disorders, including epilepsy or dementia;

• Conditions that investigators think is not suitable for inclusion.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage I

Intervention

Genetic:
• ctDNA detection
To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)

Locations

Country	Name	City	State
China	Si-Yu Wang	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause	2 years after the last patient enrolled
Secondary	Overall survival	Overall survival was assessed from surgery to death as a result of any cause	5 years after the last patient enrolled