Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis

Gastric Cancer Clinical Trial

Official title:

Identification and Multicentral Clinical Validation of Plasma Diagnostic Biomarkers for Gastric Cancer Based on Wide-targeted and Targeted Metabolomics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109805
• Other study ID #: BFHHZML20230010
• Status: Recruiting
• Start date: October 20, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Beijing Friendship Hospital
• Contact: Li Min, Ph.D.
• Phone: +86 13552652141
• Email: minli[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 30, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Gastric cancer
Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing
China	Renmin Hospital of Wuhan University	Wuhan
China	Tongji Hospital, Tongji Medical College of HUST	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma metabolite content	The outcome will be tested by metabolomics detection technology based on mass spectrometry	Before receiving treatment for gastric cancer