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Completed

NCT Number: NCT04238130

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perioperative ctDNA Dynamic Monitoring

Diagnostic Test

To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline

Primary outcomes

  1. Concordance between genomic alterations assessed by next-generation sequencing in tumor tissue and PEAC technology in circulating tumor DNA

    Time frame: 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.

  2. ctDNA dynamic monitoring

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Hangzhou Repugene Technology Co., Ltd.

Registry information

Official study title

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

Acronym: EVOLUTION

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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