Clinical trial NCT06893133: CtDNA-MRD Monitoring After Resection in Gastric Cancer
Official title: Personalized CtDNA-MRD in Recurrence Monitoring for Gastric Cancer Patients Undergoing Perioperative Treatment Combined with Curative Surgical Resection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Keywords: ctDNA
MRD
Gastric Cancer
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 110 patients with gastric cancer undergoing preoperative drug therapy combined with R0 resection were enrolled.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years of age at first visit
2. Patients have received neoadjuvant therapy and curative surgery;
3. Pathologically confirmed ypTNM stage II-III gastric or gastroesophageal junction adenocarcinoma;
4. Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS analysis;
5. Patients must be able to follow the study visit schedule;
6. Willing to cooperate with the study by providing blood samples at the indicated time point.

Exclusion Criteria:

1. Progress of preoperative drug therapy in patients
2. Non-R0 resection surgery
3. Patients with other serious disease besides early or intermediate-stage gastric cancer will be excluded.
4. Patients who are alcoholic or drug abusers will be excluded.
5. Pregnant women will be excluded.

Primary outcomes:
measure: Predictive Accuracy of Personalized ctDNA-MRD for Postoperative Recurrence
timeFrame: From the time of surgical resection to the point of resurrence within 2 years
Secondary outcomes:
measure: Lead time of personalized ctDNA-MRD compared to radiologic surveillance in postoperative recurrence prediction
timeFrame: From ctDNA-MRD positive to the point of CT imaging showing recurrence
Other outcomes:
measure: Prognostic or recurrence molecular biomarkers
timeFrame: From the time of surgical resection to the point of recurrence within 2 years
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
References:
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