Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis

April 12, 2024 updated by: Min Li, Beijing Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Yibin Xie, Ph.D.
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • Recruiting
        • Hebei Tumor Hospital
        • Contact:
          • Lianmei Zhao, Ph.D.
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
          • Qian Song, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population included a range of cancer patients and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Multi-cancer group
Patients diagnosed with cancer, including lung cancer，breast cancer，colorectal cancer，thyroid cancer，gastric cancer，cervical cancer，liver cancer，pancreatic cancer，cholangiocarcinoma，prostate cancer，esophageal cancer，ovarian cancer，renal cell carcinoma.
control group
Healthy controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma metabolite content
Time Frame: Before receiving treatment for cancer
The outcome will be tested by metabolomics detection technology based on mass spectrometry
Before receiving treatment for cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Li Min, Ph.D., Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFHHZML20240009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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