Post-operative monitoring for gastric cancer
Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
This study will test a new non-invasive blood DNA test in adults after gastric cancer surgery to see if it can predict or detect recurrence earlier than imaging and common tumor markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Huhu Health & Technology Inc. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07026240 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter observational study will collect blood at multiple time points after gastric cancer surgery to develop and validate a multi-target DNA biomarker panel. The panel will be compared with standard clinical methods such as imaging and tumor markers CA19-9, CEA, and CA72-4. Patients will be followed over time to correlate biomarker changes with confirmed recurrence or metastasis. The study will determine whether the blood biomarkers provide earlier or more reliable detection and prognostic information than current monitoring approaches.
Who should consider this trial
Good fit: Adults with gastric cancer who have had or will have surgery at the participating center, can provide required blood samples, and can give informed consent are ideal candidates.
Not a fit: Patients with serious heart, liver, or kidney dysfunction, prior malignancies, active HIV infection, or those receiving targeted, immunosuppressive, or biological therapies are excluded or may not receive benefit.
Why it matters
Potential benefit: If successful, the test could enable earlier and less invasive detection of recurrence using a simple blood sample, allowing faster treatment decisions and potentially better outcomes.
How similar studies have performed: Similar circulating tumor DNA approaches have shown promise for earlier detection of recurrence in other cancers and emerging data in gastric cancer are encouraging but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject age over 18. 2. Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center. 3. Subject has or will have gastroscopy and/or pathological examination results at this center. 4. Subject must be able to fully understand the informed consent form and be able to personally sign it. Exclusion Criteria: 1. Subject has serious heart, liver, kidney dysfunction, or mental illness. 2. Subject diagnosed previously with any kind of malignant tumor. 3. Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs). 4. Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies. 5. Researchers believe that subject is not suitable for enrollment. 6. Subject can not supply sufficient sample to complete this experiment.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dazhi Xu, MD., PhD, — Fudan University
- Study coordinator: Dazhi Xu, MD., PhD,
- Email: jiangnan@sz-hoho.com
- Phone: +86 13862036541
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.