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Trial Title:
Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis
NCT ID:
NCT06109805
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Gastric cancer
Description:
Patients diagnosed with gastric cancer, including early gastric cancer and advanced
gastric cancer
Arm group label:
Gastric cancer group
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Min, Ph. D.
Investigator:
Last name:
Liyi Bai, M.D.
Email:
Sub-Investigator
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yibin Xie, Ph.D.
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Zhu, Ph.D.
Facility:
Name:
Tongji Hospital, Tongji Medical College of HUST
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Fayong Hu, Ph.D.
Start date:
October 20, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109805
