Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis

Recruiting

• Conditions: Thyroid Cancer; Gastric Cancer; Ovarian Cancer; Renal Cell Carcinoma; Lung Cancer; Colorectal Cancer; Pancreatic Cancer; Liver Cancer; Prostate Cancer; Breast Cancer

• Registration Number: NCT06363123
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-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 multi-cancer.

Detailed Description

Firstly, a wide-targeted metabolomic measurement will be conducted on all samples to identify potential metabolite candidate markers and analyze differences in the metabolic profiles of patients with different types of cancer. Additionally, a comprehensive metabolite database specific to cancer patients will be constructed.

Secondly, Samples will be randomly allocated into modeling and testing cohorts. The modeling cohort will be further divided into training and validation sets. 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 diagnostic efficacy for cancer.

Ultimately, the testing cohort will be used to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-29
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-10
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2700

Inclusion Criteria

• Multi-Cancer Group:

  • Patients with a confirmed diagnosis based on the clinical "gold standard".
  • Collection of plasma samples prior to treatment.
  • Availability of complete clinical data.

• Control Group:

  • Individuals with no abnormalities in routine physical examinations and relevant clinical tests.
  • Age ≥ 45 years.
  • 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 treatment.
• Pregnancy status.
• No clear evidence of histopathological diagnosis (not applicable to the control group based on this criterion).
• Patients with severe acute infections.
• Patients with severe anemia.
• Patients with severe liver or kidney dysfunction.
• Patients with autoimmune deficiency diseases.
• Patients with Hyperlipidemia.
• Patients received contrast agent injection before blood draw.
• Patients with psychiatric disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma metabolite content	Before receiving treatment for cancer	The outcome will be tested by metabolomics detection technology based on mass spectrometry

Trial Locations

Locations (4)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Hebei Tumor Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China