ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage II to IIIA NSCLC by NGS

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465241
• Other study ID #: GASTO1035
• Status: Completed
• Start date: October 21, 2017
• Est. completion date: February 1, 2021

Study information

• Verified date: July 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The second generation of high-throughput gene sequencing (NGS) is an important means of detecting the tumor DNA and circulating tumor DNA (ctDNA), which can detect trace ctDNA from smaller plasma samples. This project is chiefly to study the role of ctDNA dynamic monitoring of stage IIA to IIIA NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA. And the investigators also wander the concordance of lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes.

Description:

In the NGS era, ctDNA detection can truly reflect the real tumor tissue gene mutation map and frequency. It becomes the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after surgery and adjuvant chemotherapy. 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 DNA dynamic monitoring of stage II to IIIA non-small cell lung cancer (NSCLC) was performed by the NGS technique to verify prognostic predictive effect of ctDNA in stage IIA to IIIA NSCLC patients after operation. The lung cancer related genes mutation map and frequency between primary tumors and infiltrated regional lymph nodes seems not exactly consistent. In this study, the investigators will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postoperative histopathological diagnosis of TNM stage IIA to IIIA NSCLC with R0 resection;

• No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer;

• Eastern Cooperative Oncology Group (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
• NSCLC

Intervention

Diagnostic Test:
• the ctDNA dynamic monitoring
To detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS)

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
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	the genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node	we will compare the lung cancer related genes mutation map and frequency between primary tumors, bloodstream and infiltrated lymph node by the NGS technique.	one month after the last patient enrolled