Post-operative Monitoring of Gastric Cancer

NCT07026240 | Recruiting

• 1 other identifier: 2311285-6（1）
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine the performance of non-invasive new multi-target biomarkers in the post-operative monitoring of gastric cancer.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

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

  Number of Participants With Tumor Recurrence Detected by the New System vs. Imaging and Serum Markers (CA19-9, CEA, CA72-4).

  2 years

Secondary Outcomes (1)

• Metastasis Detection Time: New vs. Conventional Methods

  2 years

Study Arms (1)

malignant group

Subjects diagnosed with gastric cancer.

Diagnostic Test: DNA test

Interventions

DNA test DIAGNOSTIC_TEST

a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood

malignant group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 258 subjects 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 (1)

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 Officials

• Dazhi Xu, MD., PhD,

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dazhi Xu, MD., PhD,

CONTACT

+86 13862036541; jiangnan@sz-hoho.com

Study Design

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

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 18, 2025
• Study Start: February 18, 2024
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)