RecruitingNCT06893133

ctDNA-MRD Monitoring After Resection in Gastric Cancer

Personalized ctDNA-MRD in Recurrence Monitoring for Gastric Cancer Patients Undergoing Perioperative Treatment Combined With Curative Surgical Resection


Sponsor

Peking University

Enrollment

110 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria3

  • 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.

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Locations(1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

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NCT06893133


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