Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis

NCT ID: NCT06109805

Last Updated: 2025-02-20

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

COMPLETED

Total Enrollment

1706 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-02-18

Brief Summary

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The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. The goal is to construct a dedicated plasma metabolite database for gastric cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.

Detailed Description

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Firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information.

Secondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy.

Ultimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.

Conditions

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Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Gastric cancer group

Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer

Gastric cancer

Intervention Type OTHER

Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer

Non-gastric cancer group

Patients diagnosed with benign gastric diseases or healthy controls

No interventions assigned to this group

Interventions

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Gastric cancer

Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of gastric cancer or benign gastric diseases through gastroscopy and pathological examination.
* Collection of plasma samples prior to surgical treatment.
* Availability of complete clinical data.

Exclusion Criteria

* Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
* Coexistence of other systemic tumors.
* Absence of plasma sample collection before surgical treatment.
* Incomplete clinical data.
* Pregnancy status.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min Li

Deputy Director of Science and Technology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Min, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Renmin Hospital of Wuhan University

Wuhan, , China

Site Status

Tongji Hospital, Tongji Medical College of HUST

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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BFHHZML20230010

Identifier Type: -

Identifier Source: org_study_id

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