Gastric Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTDNA test
circulating DNA test
Sponsors
Fudan University
Suzhou Huhu Health & Technology Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed