ctDNA-MRD Monitoring After Resection in Gastric Cancer

Active, not recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT06893133
• Lead Sponsor: Peking University

Brief Summary

Numerous studies have demonstrated that circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) detection has significant clinical value in postoperative recurrence monitoring, adjuvant treatment decision-making, and early intervention. Our previous retrospective study, using fixed ctDNA-MRD, confirmed that postoperative ctDNA-MRD can predict recurrence risk. Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence.

Detailed Description

China has the highest incidence and mortality rates of gastric cancer in the world, with approximately 70% of patients diagnosed at an advanced stage. Perioperative treatment combined with surgery is the recommended treatment approach for advanced gastric cancer. However, a considerable proportion of patients still experience recurrence and metastasis after surgery. Imaging studies are the standard method for monitoring postoperative recurrence and metastasis, but they can only detect recurrence once the metastatic lesions have grown to a certain size. In contrast, ctDNA-MRD testing can detect residual tumor molecular signals in the blood, providing early signs of recurrence and allowing for timely intervention while the tumor is still in its "incipient stage." Previous clinical data have shown that MRD testing can identify recurrent and metastatic patients months earlier than traditional imaging methods, with the median lead time varying by cancer type: 9.5 months for breast cancer, 8.7 months for colon cancer, 5.2 months for lung cancer, and 2.8 months for bladder cancer.

Therefore, we plan to conduct a further prospective, multicenter, observational study, utilizing a combination of personalized ctDNA-MRD and fixed MRD panels, to dynamically monitor gastric cancer patients who have received neoadjuvant therapy followed by curative resection. The study will systematically analyze the correlation between ctDNA-MRD status and tumor recurrence and metastasis, assess its sensitivity and specificity in recurrence prediction, and compare its early warning advantage over traditional imaging techniques in predicting recurrence. In addition, this project will focus on establishing and improving a dynamic MRD monitoring system, laying the foundation for future interventional clinical research.

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Study Start: 2025-04-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-12-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Patients have received neoadjuvant therapy and radical resection (R0).
2. Pathologically confirmed ypTNM stage II-III gastric or gastroesophageal junction adenocarcinoma.
3. Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS-WES analysis.
4. Patients must be able to follow the study visit schedule and be willing to cooperate with the study by providing blood samples at the indicated time point.

Exclusion Criteria

1. Patients who could not receive enhanced CT, gastroscopy and other routine review after surgery.
2. Patients who could not perform WES or ctDNA-MRD detection for various reasons after surgery.
3. Other cases considered unsuitable for inclusion by researchers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence	From the time of surgical resection to the point of resurrence within 2 years	Sensitivity, Specificity, and Positive predictive value of ctDNA-MRD in predicting postoperative recurrence

Secondary Outcome Measures

Name	Time	Method
Lead time of personalized ctDNA-MRD compared to radiologic surveillance in postoperative recurrence prediction	From ctDNA-MRD positive to the point of CT imaging showing recurrence	Time interval between ctDNA-MRD positivity and imaging diagnosis of recurrence

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, Beijing, China