Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis

NCT ID: NCT06363123

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-29

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

control group

Healthy controls

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min Li

Deputy Director of Science and Technology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Min, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Hebei Tumor Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Min, Ph.D.

Role: CONTACT

+86 13552652141

Bilian Kang, Ph.D.

Role: CONTACT

+86 18001218793

Facility Contacts

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Yibin Xie, Ph.D.

Role: primary

Li Min, Ph. D.

Role: primary

+86 13552652141

Bilian Kang, Ph.D.

Role: backup

+86 18001218793

Lianmei Zhao, Ph.D.

Role: primary

Qian Song, Ph.D.

Role: primary

Other Identifiers

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BFHHZML20240009

Identifier Type: -

Identifier Source: org_study_id

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