Clinical trial NCT06109805: Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis
Official title: Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 1706
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Plasma metabolite content
timeFrame: Before receiving treatment for gastric cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
Study officials:
affiliation: Beijing Friendship Hospital
name: Li Min, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: