Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection

Non-Small Cell Lung Cancer Clinical Trial

— EVOLUTION  

Official title:

Evaluation Perioperative Dynamic Changes in ctDNA From Patients of Non-Small-Cell Lung Cancer Following Resection for Relapse Prediction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238130
• Other study ID #: GASTO1058
• Status: Recruiting
• Start date: December 18, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2020
• 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

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Description:

Circulating tumor DNA (ctDNA) is a promising biomarker for noninvasive assessment of cancer burden. Advances in DNA sequencing technologies and our understanding of the molecular biology of tumours have resulted in increased interest in exploiting ctDNA as a tool to facilitate earlier detection of cancer and thereby improve therapeutic outcomes by enabling early intervention. In this study, PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline. Investigators aim to evaluate whether driver gene mutations detected by PEAC can replace tissue testing results in patients with stage I to Ⅲ NSCLC. Investigators also applied ctDNA dynamic monitoring using PEAC technology in early stage NSCLC patients with driver mutations positive at baseline, to evaluate the feasibility and their potential clinical application.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: December 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Postoperative histopathological diagnosis of TNM stage I to III NSCLC with R0 resection;

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

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

• 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
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Perioperative ctDNA Dynamic Monitoring
To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Hangzhou Repugene Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA	PEAC (Personalized Analysis of Cancer) technology was performed to detect the driver gene mutations from plasma samples and matched tumor tissue samples were detected by NGS platform at baseline.	2 years after the last patient enrolled
Primary	ctDNA dynamic monitoring	PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline	2 years after the last patient enrolled