Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07799649

ctDNA-MRD Monitoring After Neoadjuvant Therapy in Gastric Cancer With pCR or MPR

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

This prospective observational study will enroll adults with gastric or gastroesophageal junction adenocarcinoma who achieve pathological complete response or major pathological response after neoadjuvant therapy and R0 gastrectomy. The study will evaluate whether postoperative circulating tumor DNA-based molecular residual disease status can identify participants at increased risk of recurrence despite a favorable pathological response. All postoperative treatment decisions will be made by the treating clinicians according to routine care and will not be assigned by the study. Tumor-informed ctDNA-MRD testing will be performed longitudinally, and results will not be used to alter treatment. Participants will be followed for disease-free survival, overall survival, recurrence detection, and adverse events.

Official title: A Prospective, Single-Center Observational Study Evaluating Recurrence Risk Using ctDNA-Based Molecular Residual Disease Monitoring in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma Achieving Pathological Complete Response or Major Pathological Response After Neoadjuvant Therapy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-09

Completion Date

2032-04

Last Updated

2026-09-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Tumor-Informed ctDNA-MRD Monitoring

Patient-specific somatic variants identified from tumor tissue are used to construct an individualized panel for ultra-deep sequencing of plasma cell-free DNA at prespecified perioperative and follow-up time points. Results are used for observational correlation and do not guide treatment changes.

OTHER

Clinician-Selected Standard-of-Care Postoperative Treatment

Postoperative treatment is selected by treating clinicians according to guidelines and individual clinical factors. The study does not assign, randomize, or modify treatment.

Locations (1)

The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)

Nanjing, Jiangsu, China