Early Detection and Post-operative Monitoring of Gastric Cancer

Suzhou Huhu Health & Technology Inc.1,197 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,197

Conditions

Gastric Cancer

Interventions

DNA testDIAGNOSTIC_TEST

circulating DNA test

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Fudan University Shanghai Cancer Center.

Shanghai, Shanghai Municipality, China

RECRUITING

Fudan University Shanghai Cancer Center.

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

The performance of the new detection system for gastric cancer (GC) detection

Evaluate sensitivity, specificity, accuracy, ROC curve area, positive predictive value, and negative predictive value of the new biomarker for the diagnosis of gastric cancer.

Time frame: 2 years

The performance of the new biomarkers in the post-operative monitoring of gastric cancer

Determine whether the new detection system can detect tumor recurrence and metastasis earlier than imaging and tumor marker CA19-9, CEA, and CA72-4.

Time frame: 2 years

Secondary Outcomes

Compare the performance of the new biomarkers for GC detection with the conventional tumor markers

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.

Time frame: 2 years

The performance of the new biomarkers as prognostic biomarkers

Determine whether the new biomarkers cancer serve as prognostic biomarkers to predict tumor recurrence and metastasis.

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.