Post-operative Monitoring of Gastric Cancer

NCT ID: NCT07026240

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-18

Study Completion Date

2026-01-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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malignant group

Subjects diagnosed with gastric cancer.

DNA test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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DNA test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role collaborator

Suzhou Huhu Health & Technology Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dazhi Xu, MD., PhD,

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dazhi Xu, MD., PhD,

Role: CONTACT

+86 13862036541

Facility Contacts

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Dazhi Xu, MD., PhD

Role: primary

+8615862461212

Other Identifiers

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2311285-6(1)

Identifier Type: -

Identifier Source: org_study_id

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