About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients have received neoadjuvant therapy and radical resection (R0).
Pathologically confirmed ypTNM stage II-III gastric or gastroesophageal junction adenocarcinoma.
Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS-WES analysis.
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.
Disqualifiers
Patients who could not receive enhanced CT, gastroscopy and other routine review after surgery.
Patients who could not perform WES or ctDNA-MRD detection for various reasons after surgery.
Other cases considered unsuitable for inclusion by researchers.
Trial population
110 patients with gastric cancer undergoing preoperative drug therapy combined with R0 resection were enrolled.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence
Sensitivity, Specificity, and Positive predictive value of ctDNA-MRD in predicting postoperative recurrence
Secondary outcomes
Lead time of personalized ctDNA-MRD compared to radiologic surveillance in postoperative recurrence prediction
Time interval between ctDNA-MRD positivity and imaging diagnosis of recurrence
Other outcomes
Prognostic or recurrence molecular biomarkers
Prognostic or recurrence molecular biomarkers associated with postoperative recurrence and metastasis
Sponsors and contacts
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Peking University
Lead sponsor
Peking University Cancer Hospital & Institute
Sponsor institution