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

Sun Yat-sen University

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Treatments: Diagnostic Test: Perioperative ctDNA Dynamic Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04238130

GASTO1058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

132 participants in 1 patient group

Perioperative ctDNA Dynamic Monitoring Group

Description:

Samples were obtained at multiple pre-specified time points including before surgery (plasma samples)，during surgery after tumor resection (tumor samples) and after surgery(plasma samples were obtained every 6 months from ctDNA positive patients at baseline in the following 2 years)

Treatment:

Diagnostic Test: Perioperative ctDNA Dynamic Monitoring