Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis

Breast Cancer Clinical Trial

Official title:

Identification and Validation of Plasma Diagnostic Biomarkers for Multi-Cancer Based on Metabolomics: A Multi-Center Clinical Research and Validation Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363123
• Other study ID #: BFHHZML20240009
• Status: Recruiting
• Start date: March 29, 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Renal Cell
• Cervical Cancer
• Cholangiocarcinoma
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Liver Cancer
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Renal Cell Carcinoma
• Thyroid Cancer

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Hebei Tumor Hospital	Shijiazhuang	Hebei

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 cancer