Evaluation ctDNA in Patients of Non-Small-Cell Lung Cancer Following Resection
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Diagnostic Test: Perioperative ctDNA Dynamic Monitoring
- Registration Number
- NCT04238130
- Lead Sponsor
- Sun Yat-sen University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Perioperative ctDNA Dynamic Monitoring Group Perioperative ctDNA Dynamic Monitoring 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)
- Primary Outcome Measures
Name Time Method Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA 2 years after the last patient enrolled 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.
ctDNA dynamic monitoring 2 years after the last patient enrolled PEAC technology was performed to apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China