NCT07795528

ctDNA-MRD Monitoring for Stage I-III Resectable Colon Adenocarcinoma With Oncogenic Driver Mutations: A Multicenter Prospective Cohort Study

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Reclutando

Descripción

This is a multicenter, prospective, observational cohort study enrolling 392 patients with stage I-III radically resectable colon adenocarcinoma carrying at least one oncogenic driver mutation (KRAS, NRAS, BRAF, PIK3CA). Serial plasma ctDNA-MRD testing via a standardized 10-gene NGS panel will be performed at predefined time points during 3-year postoperative follow-up. The primary objective is to evaluate the correlation between postoperative ctDNA-MRD status and recurrence-free survival (RFS). Secondary objectives include overall survival (OS), time advantage of MRD for early recurrence warning ahead of radiology, and correlation between dynamic MRD changes and adjuvant treatment efficacy. Exploratory analysis will compare MRD detection rate and prognostic performance across distinct driver mutation subtypes, aiming to build an integrated risk stratification model combining driver genotype and longitudinal MRD monitoring to guide individualized adjuvant therapy for colon cancer patients.

Evidencia de la diana molecular en cáncer colorrectal

Estos fármacos NO son el fármaco de este ensayo. Es la eficacia publicada de OTROS fármacos que atacan la misma diana molecular, mostrada como contexto — no se refiere a este ensayo concreto ni confirma elegibilidad. Revísalo siempre con tu oncólogo.

Aún no hay evidencia documentada en nuestra base para la diana o el fármaco de este ensayo. Esta sección crece a medida que se procesan nuevas publicaciones.

Criterios de Elegibilidad

Inclusion Criteria:

1. Age 18-75 years, any gender

2. Pathologically confirmed colon adenocarcinoma, clinical stage I-III without preoperative endoscopic radical resection (ESD/EMR)

3. Planned curative surgical resection, no prior anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy) before surgery

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

5. Tumor tissue positive for at least one driver mutation among KRAS, NRAS, BRAF, PIK3CA

6. Voluntary participation with signed written informed consent, good compliance to scheduled follow-up and blood collection -

Exclusion Criteria:

1. Received neoadjuvant chemotherapy, radiotherapy or targeted therapy before surgery

2. History of other malignant tumors (excluding non-adenomatous colorectal neoplasms)

3. Pregnant or breastfeeding women

4. Severe concurrent systemic diseases that interfere with long-term follow-up or short-term survival (uncontrolled severe infection, organ failure, mental disorders etc.)

5. Abnormal laboratory values or social/family factors judged by investigator to impede sample collection and follow-up

6. Simultaneous participation in other interventional clinical trials with mandatory assigned postoperative treatment regimen

Información del Ensayo

Número NCT NCT07795528

Estado Reclutando

Fase Sin fase definida

Inscripción 392 participantes

Fecha de Inicio Ago 2026

Finalización Est. Dic 2030

Ubicaciones1

China (1)

Ruijin Hospital North

Shanghai

Fuente Oficial

Ver en ClinicalTrials.gov