Early Detection and Post-operative Monitoring of Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- Diagnostic Test: DNA test
- Registration Number
- NCT06232395
- Lead Sponsor
- SUZHOU HUHU HEALTH & TECHNOLOGY Inc.,
- Brief Summary
This study is to determine the performance of non-invasive new multi-target biomarkers in the early detection and post-operative monitoring of gastric cancer.
- Detailed Description
This study aims to develop and validate a new non-invasive detection method for early detection and postoperative monitoring of gastric cancer in the blood. Sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarkers in the diagnosis of gastric cancer will be compared with that of tumor biomarkers CA19-9, CEA, and CA72-4. Blood will also be collected at various time points post-operatively. The investigators will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. The investigators will also determine whether these new biomarkers detect tumor recurrence and metastasis earlier than methods currently used in the clinic such as imaging and tumor biomarkers CA19-9, CEA, and CA72-4.
This study is a prospective and multi-center study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1197
- Subject age over 18.
- Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
- Subject has or will have gastroscopy and/or pathological examination results at this center.
- Subject must be able to fully understand the informed consent form and be able to personally sign it.
- Subject has serious heart, liver, kidney dysfunction, or mental illness.
- Subject diagnosed previously with any kind of malignant tumor.
- Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
- Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
- Researchers believe that subject is not suitable for enrollment.
- Subject can not supply sufficient sample to complete this experiment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description malignant group DNA test Subjects diagnosed with gastric cancer. non-malignant group DNA test Healthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases.
- Primary Outcome Measures
Name Time Method The performance of the new biomarkers in the post-operative monitoring of gastric cancer 2 years Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4.
The performance of the new detection system for gastric cancer (GC) detection 2 years Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer.
- Secondary Outcome Measures
Name Time Method The performance of the new biomarkers as prognostic biomarkers 2 years Determine whether the new biomarkers cancer serve as prognostic biomarkers to predict tumor recurrence and metastasis.
Compare the performance of the new biomarkers for GC detection with the conventional tumor markers 2 years Determine whether the performance of the new biomarker detection system is better than that of tumor markers CA19-9, CEA, and CA72-4 in the diagnosis of gastric cancer.
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center.
🇨🇳Shanghai, Shanghai, China