Gastric Cancer
Conditions
Brief summary
This study is to determine the performance of non-invasive new multi-target biomarkers in the post-operative monitoring of gastric cancer.
Detailed description
This study aims to develop and validate a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood. Blood will also be collected at various time points post-operatively. We will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. We 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
a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood
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
No
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 biomarkers in the post-operative monitoring of gastric cancer | 2 years | Number of Participants With Tumor Recurrence Detected by the New System vs. Imaging and Serum Markers (CA19-9, CEA, CA72-4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metastasis Detection Time: New vs. Conventional Methods | 2 years | Time to Detection of Metastasis (Days) by the New System Compared to Conventional Methods. |
Countries
China
Contacts
Primary ContactDazhi Xu, MD., PhD,
Outcome results
None listed