Early Detection and Post-operative Monitoring of Gastric Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Diagnostic test: DNA test

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.

• Study Type: Observational
• Enrollment (Estimated): 1197

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center.
      • Contact: Nan Jiang; Phone Number: +8615862461212; Email: jn100@qq.com
      • Contact: Dazhi Xu, MD., PhD; Phone Number: +8613862036541; Email: jiangnan@sz-hoho.com
      • Principal Investigator: Dazhi Xu, MD., PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects age over 18, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. More than 1197subjects are targeted to enroll.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
malignant group; Subjects diagnosed with gastric cancer.	Diagnostic test: DNA test; circulating DNA test
non-malignant group; Healthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases.	Diagnostic test: DNA test; circulating DNA test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Suzhou Huhu Health & Technology Inc.
• Collaborators: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Estimated): February 17, 2026
• Study Completion (Estimated): February 17, 2026

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 2311285-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No