ctDNA-MRD Monitoring After Resection in Gastric Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 1 trial group
Group A: Preoperative drug therapy combined with R0 resection in patients with gastric cancer

Trial outcomes

Primary outcomes

1

Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence

Sensitivity, Specificity, and Positive predictive value of ctDNA-MRD in predicting postoperative recurrence

Time frame
From the time of surgical resection to the point of resurrence within 2 years

Secondary outcomes

1

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

Time frame
From ctDNA-MRD positive to the point of CT imaging showing recurrence

Other outcomes

1

Prognostic or recurrence molecular biomarkers

Prognostic or recurrence molecular biomarkers associated with postoperative recurrence and metastasis

Time frame
From the time of surgical resection to the point of recurrence within 2 years

Sponsors and contacts

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Peking University

Lead sponsor

Peking University Cancer Hospital & Institute

Sponsor institution