Clinical trial NCT06363123: Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis
Official title: Identification and Validation of Plasma Diagnostic Biomarkers for Multi-Cancer Based on Metabolomics: A Multi-Center Clinical Research and Validation Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 2700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma metabolite content
timeFrame: Before receiving treatment for cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Shijiazhuang
country: China
facility: Hebei Tumor Hospital
state: Hebei
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Friendship Hospital
name: Li Min, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: