Early Detection and Post-operative Monitoring of Gastric Cancer

NCT06232395 | Recruiting

• 1 other identifier: 2311285-6
• Study Type: observational
• Target: 1,197
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  2 years

• The performance of the new biomarkers as prognostic biomarkers

  2 years

Study Arms (2)

malignant group

Subjects diagnosed with gastric cancer.

Diagnostic Test: DNA test

non-malignant group

Healthy individuals and subjects with gastritis, gastric ulcer, gastric polyp or other benign gastric diseases.

Diagnostic Test: DNA test

Interventions

DNA test DIAGNOSTIC_TEST

circulating DNA test

malignant group; non-malignant group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject age over 18.
• Subject has stomach discomfort, and seek medical attention at the Gastric Surgery Department of our center.
• Subject has or will have gastroscopy and/or pathological examination results at this center.
• Subject must be able to fully understand the informed consent form and be able to personally sign it.

You may not qualify if:

• Subject has serious heart, liver, kidney dysfunction, or mental illness.
• Subject diagnosed previously with any kind of malignant tumor.
• Subject is known to be infected with HIV or other related diseases (considering interference from the use of immune drugs).
• Subject is receiving targeted drugs, immunosuppressants, immunomodulators, and biological therapies.
• Researchers believe that subject is not suitable for enrollment.
• Subject can not supply sufficient sample to complete this experiment.

Sponsors & Collaborators

• Suzhou Huhu Health & Technology Inc.: lead
• Fudan University: collaborator

Study Sites (2)

Fudan University Shanghai Cancer Center.

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center.

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples collected from each study participant.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Human Papillomavirus DNA Tests

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Molecular Diagnostic Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 30, 2024
• Study Start: February 18, 2024
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)