Early Detection and Post-operative Monitoring of Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Early Detection and Post-operative Monitoring of Gastric Cancer Using Circulating DNA in Blood Samples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232395
• Other study ID #: 2311285-6
• Status: Recruiting
• Start date: February 18, 2024
• Est. completion date: February 17, 2026

Study information

• Verified date: January 2024
• Source: SUZHOU HUHU HEALTH & TECHNOLOGY Inc.,
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1197
• Est. completion date: February 17, 2026
• Est. primary completion date: February 17, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Diagnostic Test:
• DNA test
circulating DNA test

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center.	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center.	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
SUZHOU HUHU HEALTH & TECHNOLOGY Inc.,	Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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.	2 years
Secondary	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.	2 years
Secondary	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.	2 years