A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Head and Neck Cancer in Southern China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05969262
• Other study ID #: NFEC-2023-123
• Status: Recruiting
• Start date: March 25, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: August 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Dynamic changes in the internal environment of the body are important clues for early detection, diagnosis and even cure of head and neck tumors. This project uses the combination of proteomics technology and liquid biopsy to provide more primary prevention strategies for early intervention, secondary prevention strategies for early detection and treatment, and clues for the study of the mechanism of dynamic evolution of head and neck tumors.

Description:

Head and neck cancer is the seventh most common malignant tumor in the world, and China is a country with a high incidence of head and neck cancer. Dynamic changes in the internal environment of the body are important clues for early detection, diagnosis and even cure of head and neck tumors. The occurrence and development of head and neck cancer is complex, so it is particularly important to explore the changes of internal environment in its clinical pathway. Therefore, we conducted this study to investigate the changes of plasma and urine metabolites during the development of head and neck cancer.

(1) Retrospective cohort: 250 patients were recruited, including 125 patients with Head and neck cancer and 125 healthy people.,(2) Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people. During the course of the study, the subjects will not be given or provided with any randomized or any treatment driven by the study protocol. If it is clinically applicable, the treatment physician shall make the treatment decision and choose the treatment plan at his discretion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2025
• Est. primary completion date: April 1, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Head and neck cancer patients

• Age 18-75 years old;

• Male or non-pregnant female;

• Patients who were normatively diagnosed as head and neck tumors according to the WHO standards of 2017;

• The general situation is good: KPS score =70;

• No other malignant tumors.

2. Healthy people

• Age 18-75 years old;

• Male or non-pregnant female;

• No history of head and neck related diseases or other diseases known to affect blood lipid/protein metabolism.

Exclusion Criteria:

• Previous history of non-research related head and neck conditions or other known effects on blood metabolism (except for controlled type 2 diabetes);

• With a history of other malignancies (except cell carcinoma and cervical carcinoma in situ);

• Diseases that require long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency disorders or active central nervous system rotations, metastatic cancer, active infection, or uncontrolled heart disease;

• Concurrent with other uncontrolled serious medical conditions, such as unstable heart disease that requires treatment Disease, poorly controlled diabetes (fasting blood glucose > 1.5× the upper limit of normal), mental illness and a history of severe allergies.

• BMI less than 18 or greater than 25.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Metabolite

Intervention

Diagnostic Test:
• Proteomics technology and liquid biopsy
using proteomics technology and liquid biopsy to investigate the changes of plasma and urine metabolites in different liver diseases during the development of liver cancer by collecting residual blood and urine from routine diagnosis and treatment or physical examination

Locations

Country	Name	City	State
China	Southern medical university	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achieve the expected number of enrolled cases	Retrospective cohort: 250 patients were recruited, including 125 patients with head and neck cancer, 125 healthy people.; Prospective cohort: 250 patients were recruited, including 125 head and neck cancer patients and 125 healthy people.	3 years