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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Experimental

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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