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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Peking University Cancer Hospital & Institute
RECRUITING
Beijing
Contact Information
Primary
Ziyu Li, MD.,PhD
ziyu_li@hsc.pku.edu.cn
0086-10-88121122
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 110
Treatments
Preoperative drug therapy combined with R0 resection in patients with gastric cancer
Names: MRD testing Description: MRD refers to the small, residual number of cancer cells that remain in a patient's body after treatment, often undetectable by conventional methods, but detectable using ctDNA. MRD-positive indicates the presence of residual disease, while MRD-negative suggests potential cure.
Related Therapeutic Areas
Sponsors
Leads: Peking University

This content was sourced from clinicaltrials.gov