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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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Guangdong
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Guangzhou, Guangdong, Kina, 510030
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Experimentell
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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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.
Tidsram: From enrollment to the end of follow up at 3 years
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From enrollment to the end of follow up at 3 years
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Sekundära resultatmått
Resultatmått |
Tidsram |
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"Leading time" is defined as the time interval by which tumor recurrence detected by MRD precedes recurrence detected by imaging （CT/MRI/PET-CT ）.
Tidsram: From enrollment to the end of follow up at 3 years
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From enrollment to the end of follow up at 3 years
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OS is determined as the time from treatment to death.
Tidsram: From enrollment to the end of follow up at 3 years
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From enrollment to the end of follow up at 3 years
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Wang Minghui, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SYSEC-KY-KS-2022-053
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