NCT06109805

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,706

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

October 26, 2023

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Plasma metabolite content

    The outcome will be tested by metabolomics detection technology based on mass spectrometry

    Before receiving treatment for gastric cancer

Study Arms (2)

Gastric cancer group

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

Other: Gastric cancer

Non-gastric cancer group

Patients diagnosed with benign gastric diseases or healthy controls

Interventions

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

Gastric cancer group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population included a range of subjects with gastric and non-gastric cancer, including patients with benign gastric disease and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

Tongji Hospital, Tongji Medical College of HUST

Wuhan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only metabolites will be detected and analyzed in this study.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Li Min, Ph.D.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Science and Technology Department

Study Record Dates

First Submitted

October 26, 2023

First Posted

October 31, 2023

Study Start

October 20, 2023

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations