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

January 4, 2023 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who met the diagnosis and criteria and were admitted to Nanfang Hospital of Southern Medical University.

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EBV virus infector
QPCR/EBV antibody, diagnosed as EBV infection patient
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
nasopharyngeal carcinoma patients
Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard)
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
Healthy people
healthy people with no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achieve the expected number of enrolled cases
Time Frame: 3 years
Achieve the expected number of enrolled cases
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2022

Primary Completion (Anticipated)

November 20, 2025

Study Completion (Anticipated)

December 20, 2025

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2022-470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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