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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510030
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Expérimental
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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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 ）.
Délai: 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.
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Wang Minghui, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SYSEC-KY-KS-2022-053
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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