Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis

NCT06363123 | Recruiting

• 1 other identifier: BFHHZML20240009
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• Plasma metabolite content

  The outcome will be tested by metabolomics detection technology based on mass spectrometry

  Before receiving treatment for cancer

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Hebei Tumor Hospital

Shijiazhuang, Hebei, 050010, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Only metabolites will be detected and analyzed in this study.

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Thyroid Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Liver Neoplasms; Pancreatic Neoplasms; Cholangiocarcinoma; Prostatic Neoplasms; Esophageal Neoplasms; Ovarian Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Stomach Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Liver Diseases; Pancreatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Esophageal Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases

Study Officials

• Li Min, Ph.D.

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Min, Ph.D.

CONTACT

+86 13552652141; minli@ccmu.edu.cn

Bilian Kang, Ph.D.

CONTACT

+86 18001218793; kbl@mail.ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Science and Technology Department

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: March 29, 2024
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-03

Locations

CN (4)