Clinical trial · Observational
Tumor-informed MRD for Non-small Cell Lung Cancer
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
NCT07596433CI-TRIAL-00111982active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Experimental
Primary outcomes (1)
- measure
- 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.
- timeFrame
- From enrollment to the end of follow up at 3 years
Secondary outcomes (2)
- measure
- "Leading time" is defined as the time interval by which tumor recurrence detected by MRD precedes recurrence detected by imaging （CT/MRI/PET-CT ）.
- timeFrame
- From enrollment to the end of follow up at 3 years
- measure
- OS is determined as the time from treatment to death.
- timeFrame
- From enrollment to the end of follow up at 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTCargnin 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
- RESULTSardarabadi 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