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Recruiting

NCT Number: NCT07026240

Post-operative Monitoring of Gastric Cancer

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Dazhi Xu, MD., PhD

CONTACT

[email protected]

+8615862461212

About this study

This study aims to develop and validate a new non-invasive detection method for postoperative monitoring of gastric cancer in the blood. Blood will also be collected at various time points post-operatively. We will determine whether these new biomarkers can be used as prognostic biomarkers to predict tumor recurrence and metastasis. We 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

DNA test

Diagnostic Test

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

Primary outcomes

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

    Time frame: 2 years

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

Secondary outcomes

  1. Metastasis Detection Time: New vs. Conventional Methods

    Time frame: 2 years

    Time to Detection of Metastasis (Days) by the New System Compared to Conventional Methods.

Study contacts

Contact information is provided by the study sponsor or research team.

Dazhi Xu, MD., PhD,

CONTACT

[email protected]

+86 13862036541

Sponsors and collaborators

Lead sponsor

Suzhou Huhu Health & Technology Inc.

Industry

Collaborators

  • Fudan University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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