Monitoring ctDNA for recurrence in gastric cancer patients after surgery
Personalized ctDNA-MRD in Recurrence Monitoring for Gastric Cancer Patients Undergoing Perioperative Treatment Combined With Curative Surgical Resection
This study is testing if checking for cancer DNA in the blood can help doctors find out if gastric cancer patients are at risk of their cancer coming back after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06893133 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor gastric cancer patients who have undergone neoadjuvant therapy followed by curative resection by utilizing circulating tumor DNA (ctDNA) to detect molecular residual disease (MRD). The study will analyze the relationship between ctDNA-MRD status and tumor recurrence, assessing its sensitivity and specificity in predicting recurrence compared to traditional imaging techniques. By identifying residual tumor signals in the blood, the study seeks to provide early warnings of recurrence, potentially allowing for timely interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed stage II-III gastric or gastroesophageal junction adenocarcinoma who have received neoadjuvant therapy and curative surgery.
Not a fit: Patients who have not undergone R0 resection surgery or those with other serious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of gastric cancer recurrence, leading to improved patient outcomes through timely interventions.
How similar studies have performed: Previous studies have shown that ctDNA-MRD testing can identify recurrences earlier than traditional imaging methods, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients have received neoadjuvant therapy and radical resection (R0). 2. Pathologically confirmed ypTNM stage II-III gastric or gastroesophageal junction adenocarcinoma. 3. Patients must be able to provide sufficient fresh tissue/biopsies or minimum 5-10 FFPE sections for NGS-WES analysis. 4. 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 Criteria: 1. Patients who could not receive enhanced CT, gastroscopy and other routine review after surgery. 2. Patients who could not perform WES or ctDNA-MRD detection for various reasons after surgery. 3. Other cases considered unsuitable for inclusion by researchers.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Cancer Hospital & Institute — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ziyu Li, MD.,PhD
- Email: ziyu_li@hsc.pku.edu.cn
- Phone: 0086-10-88121122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.