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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Guangdong
-
Guangzhou, Guangdong, Porcelana, 510030
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Experimental
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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.
Periodo de tiempo: From enrollment to the end of follow up at 3 years
|
From enrollment to the end of follow up at 3 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
"Leading time" is defined as the time interval by which tumor recurrence detected by MRD precedes recurrence detected by imaging （CT/MRI/PET-CT ）.
Periodo de tiempo: 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.
Periodo de tiempo: From enrollment to the end of follow up at 3 years
|
From enrollment to the end of follow up at 3 years
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Wang Minghui, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SYSEC-KY-KS-2022-053
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .