A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Nasopharyngeal Carcinoma.

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites During the Occurrence and Development of Nasopharyngeal Carcinoma in Southern China.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682703
• Other study ID #: NFEC-2022-470
• Status: Recruiting
• Start date: December 23, 2022
• Est. completion date: December 20, 2025

Study information

• Verified date: December 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: jian guan, MD
• Phone: 136 3210 2247
• Email: guanjian5461[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The transformation process of nasopharyngeal carcinoma is complex, so it is particularly important to explore the relationship between various disease states on its clinical pathway. Therefore, we carried out this study to explore the changes of plasma and urine metabolites at different stages during the occurrence and development of nasopharyngeal carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 20, 2025
• Est. primary completion date: November 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• EBV virus infector: QPCR/EBV antibody, diagnosed as EBV infection patient with previous infection;
• Nasopharyngeal carcinoma patients:Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard);
• Healthy people: Healthy people who have no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism and have been hospitalized in the Physical Examination Center of Southern Hospital.

Exclusion Criteria:

1. People who have a history of non research related liver diseases or other diseases known to affect blood metabolism (except for controlled type II diabetes);

2. Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ;

3. Diseases requiring long-term use of immunosuppressive drugs (including steroids), including but not limited to congenital or acquired immunodeficiency diseases or active central nervous system metastatic cancer, active infection or uncontrolled heart disease;

4. Suffer from other uncontrolled serious diseases at the same time, such as unstable heart disease requiring treatment, diabetes with unsatisfactory control (fasting blood glucose>1.5 × Upper limit of normal value), mental illness and severe allergic history.

5. BMI is less than 18 or more than 25. -

Related Conditions & MeSH terms

• Carcinoma
• EBV Infection
• Epstein-Barr Virus Infections
• Nasopharyngeal Carcinoma

Intervention

Diagnostic Test:
• Proteomics technology and liquid biopsy
using proteomics technology and liquid biopsy to investigate the changes of plasma and urine metabolites 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 of 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	Achieve the expected number of enrolled cases	3 years