Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-30 @ 6:14 PM
Study NCT ID:
NCT06893133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA-MRD Monitoring After Resection in Gastric Cancer
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
Personalized ctDNA-MRD in Recurrence Monitoring for Gastric Cancer Patients Undergoing Perioperative Treatment Combined With Curative Surgical Resection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRD-GC
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: