An Observational Study on the Prediction of Recurrence Risk in Early-stage Non-small Cell Lung Cancer Using a Customized MRD Monitoring Scheme Based on Tumor Tissue WES
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 450
- Locations
- 1
Study Overview
Brief Summary
The goal of this study is to evaluate the clinical utility of a personalized, WES-informed MRD detection approach in patients with early-stage non-small cell lung cancer, with a focus on its association with postoperative recurrence and prognosis, as well as its ability to predict recurrence earlier than imaging.
Detailed Description
Background:
Non-small cell lung cancer (NSCLC) is associated with a high risk of postoperative recurrence despite curative-intent surgery. Minimal residual disease (MRD) detection using circulating tumor DNA (ctDNA) has emerged as a promising approach for early identification of molecular relapse. Tumor-informed strategies based on whole-exome sequencing (WES) enable personalized MRD monitoring with improved sensitivity and specificity.
Objective:
To evaluate the clinical utility of a personalized, WES-informed MRD detection approach in patients with early-stage NSCLC, focusing on its association with postoperative recurrence and prognosis, its ability to predict recurrence earlier than imaging, and its role in assessing treatment efficacy.
Methods:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
- •Newly diagnosed patients who are planned to undergo surgical treatment;
- •Age ≥18 years, regardless of sex;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
- •Written informed consent must be obtained prior to any study-related procedures, sampling, or analyses; patients must be able to provide sufficient tissue and/or blood samples required for the study, with tumor cell content ≥20% as confirmed by pathological assessment;
- •Ability to comply with study requirements, including assessment of treatment efficacy, adverse events, and prognosis;
- •Willingness to undergo next-generation sequencing (NGS) testing.
Exclusion Criteria
- •Patients unwilling to provide tissue and blood samples for genetic testing;
- •Patients who are mentally or medically unstable, rendering them unable or unwilling to provide written informed consent;
- •Patients deemed by the investigator to be unsuitable for participation in the study, or those with poor compliance with study procedures, restrictions, and requirements.