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Recruiting NCT07026240

Post-operative Monitoring of Gastric Cancer

Observational Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DNA test.
Who it may be relevant to
Registry conditions: Gastric Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

  • The performance of the new biomarkers in the post-operative monitoring of gastric cancer [Time frame: 2 years]
Secondary outcome measures (1)
  • Metastasis Detection Time: New vs. Conventional Methods [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07026240 · 2311285-6(1)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗