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Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06363123
Enrollment
2700
Registered
2024-04-12
Start date
2024-03-29
Completion date
2025-04-30
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Plasma metabolite contentBefore receiving treatment for cancerThe outcome will be tested by metabolomics detection technology based on mass spectrometry

Countries

China

Contacts

Primary ContactLi Min, Ph.D.
minli@ccmu.edu.cn+86 13552652141
Backup ContactBilian Kang, Ph.D.
kbl@mail.ccmu.edu.cn+86 18001218793

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026