Detecting and Monitoring Gastric Cancer Early
Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples
This study is testing a new blood test to see if it can help find gastric cancer earlier and monitor it better after surgery compared to current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1197 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Huhu Health & Technology Inc. Industry-sponsored |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06232395 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing and validating a new non-invasive method for the early detection and postoperative monitoring of gastric cancer using multi-target biomarkers found in the blood. It aims to compare the performance of these new biomarkers against existing tumor biomarkers such as CA19-9, CEA, and CA72-4 in terms of sensitivity, specificity, and accuracy. Blood samples will be collected at various time points after surgery to assess the potential of these biomarkers in predicting tumor recurrence and metastasis earlier than current clinical methods. The study is designed as a prospective, multi-center observational study.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 experiencing stomach discomfort who are seeking medical attention and undergoing gastroscopy or pathological examination.
Not a fit: Patients with serious organ dysfunction, previous malignancies, or those receiving certain immunosuppressive therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better monitoring of gastric cancer, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using non-invasive biomarkers for cancer detection, but this specific approach is novel.
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 and 1 other locations
- Fudan University Shanghai Cancer Center. — Shanghai, Shanghai Municipality, China (Recruiting)
- Fudan University Shanghai Cancer Center. — Shanghai, Shanghai Municipality, China (Recruiting)
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.