Tumor-informed MRD for Non-small Cell Lung Cancer

NCT07596433 | Active Not Recruiting

• 1 other identifier: SYSEC-KY-KS-2022-053
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

non-small cell lung cancer; WES; MRD

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of follow up at 3 years

Secondary Outcomes (2)

• "Leading time" is defined as the time interval by which tumor recurrence detected by MRD precedes recurrence detected by imaging （CT/MRI/PET-CT ）.

  From enrollment to the end of follow up at 3 years

• OS is determined as the time from treatment to death.

  From enrollment to the end of follow up at 3 years

Study Arms (1)

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510030, China

Location

Related Publications (2)

• Cargnin S, Canonico PL, Genazzani AA, Terrazzino S. Quantitative Analysis of Circulating Cell-Free DNA for Correlation with Lung Cancer Survival: A Systematic Review and Meta-Analysis. J Thorac Oncol. 2017 Jan;12(1):43-53. doi: 10.1016/j.jtho.2016.08.002. Epub 2016 Aug 16.

  PMID: 27543256 RESULT

• Sardarabadi P, Kojabad AA, Jafari D, Liu CH. Liquid Biopsy-Based Biosensors for MRD Detection and Treatment Monitoring in Non-Small Cell Lung Cancer (NSCLC). Biosensors (Basel). 2021 Oct 15;11(10):394. doi: 10.3390/bios11100394.

  PMID: 34677350 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wang Minghui

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: February 18, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 19, 2026

Record last verified: 2026-04

Locations

CN (1)