Tumor-informed MRD for Non-small Cell Lung Cancer

May 13, 2026 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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:

This is a single-center, prospective, observational study enrolling 450 patients with newly diagnosed stage IIB-III NSCLC undergoing surgical treatment. Tumor tissue and matched blood samples will undergo WES to identify patient-specific somatic mutations for the development of individualized MRD panels. Serial plasma samples will be collected at predefined time points before and after surgery, during neoadjuvant/adjuvant therapy, and throughout follow-up. MRD status will be dynamically monitored using ctDNA analysis.

Endpoints:

The primary endpoint is recurrence-free survival (RFS). Secondary endpoints include lead time between MRD detection and imaging-confirmed recurrenceand correlation between MRD status and treatment outcomes.

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Newly diagnosed patients with non-small cell lung cancer (NSCLC) who are planned to undergo surgical treatment and are willing to undergo next-generation sequencing (NGS) testing.

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC);
  2. Newly diagnosed patients who are planned to undergo surgical treatment;
  3. Age ≥18 years, regardless of sex;
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1;
  5. 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;
  6. Ability to comply with study requirements, including assessment of treatment efficacy, adverse events, and prognosis;
  7. Willingness to undergo next-generation sequencing (NGS) testing.

Exclusion Criteria:

  1. Patients unwilling to provide tissue and blood samples for genetic testing;
  2. Patients who are mentally or medically unstable, rendering them unable or unwilling to provide written informed consent;
  3. Patients deemed by the investigator to be unsuitable for participation in the study, or those with poor compliance with study procedures, restrictions, and requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RFS is determined as the duration from the date of surgery to the date of first detected disease recurrence or metastasis or death from any cause, whichever occurs first.
Time Frame: From enrollment to the end of follow up at 3 years
From enrollment to the end of follow up at 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
"Leading time" is defined as the time interval by which tumor recurrence detected by MRD precedes recurrence detected by imaging （CT/MRI/PET-CT ）.
Time Frame: From enrollment to the end of follow up at 3 years
From enrollment to the end of follow up at 3 years
OS is determined as the time from treatment to death.
Time Frame: From enrollment to the end of follow up at 3 years
From enrollment to the end of follow up at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Wang Minghui, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSEC-KY-KS-2022-053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer (NSCLC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe