Nasopharyngeal CarcinomaNCT05682703
A Bidirectional Study in Exploring the Dynamic Changes of Plasma and Urine Metabolites of Nasopharyngeal Carcinoma.
An observational study of Nasopharyngeal Carcinoma and EBV Infection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma, EBV Infection
- What is being tested?
- Proteomics technology and liquid biopsy
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2022to 20 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who met the diagnosis and criteria and were admitted to Nanfang Hospital of Southern Medical University.
Who may be able to join
- 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.
Who cannot join
- 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);
- Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ;
- 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;
- 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.
- BMI is less than 18 or more than 25. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern medical university
Guangzhou, Guangdong, 510515
Jian Guan, M.D., 86+13632102247, guanjian5461@163.com
Jian Guan, M.D.
About this study
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.
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.
- Conditions
- Nasopharyngeal Carcinoma, EBV Infection
- Being tested
- Proteomics technology and liquid biopsy
- Medical subject headings
- Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomics technology and liquid biopsyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| EBV virus infector | QPCR/EBV antibody, diagnosed as EBV infection patient Receives: Diagnostic Test: Proteomics technology and liquid biopsy | |
| nasopharyngeal carcinoma patients | Patients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard) Receives: Diagnostic Test: Proteomics technology and liquid biopsy | |
| Healthy people | healthy people with no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism Receives: Diagnostic Test: Proteomics technology and liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve the expected number of enrolled cases
Achieve the expected number of enrolled cases
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start23 Dec 2022
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jian guan, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682703
- Sponsor's protocol ID
- NFEC-2022-470
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2023
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Z, Tang T, Li N, Zheng Q, Xiao T, Tian Y, Sun J, Zhang L, Wang X, Wang Y, Ye F, Chen Z, Zhang H, Zheng X, Cai Z, Liu L, Guan J. VLDL and LDL Subfractions Enhance the Risk Stratification of Individuals Who Underwent Epstein-Barr Virus-Based Screening for Nasopharyngeal Carcinoma: A Multicenter Cohort Study. Adv Sci (Weinh). 2024 Jun;11(22):e2308765. doi: 10.1002/advs.202308765. Epub 2024 Mar 23.
PubMed 38520712
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05682703
- Acronym / sponsor ID
- NFEC-2022-470
- Conditions
- Nasopharyngeal Carcinoma, EBV Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EBV virus infector | – | Diagnostic Test: Proteomics technology and liquid biopsyQPCR/EBV antibody, diagnosed as EBV infection patient |
| nasopharyngeal carcinoma patients | – | Diagnostic Test: Proteomics technology and liquid biopsyPatients diagnosed as nasopharyngeal carcinoma by pathological diagnosis (2018 WHO standard) |
| Healthy people | – | Diagnostic Test: Proteomics technology and liquid biopsyhealthy people with no history of nasopharynx related diseases or other known diseases that may affect blood lipid/protein metabolism |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who met the diagnosis and criteria and were admitted to Nanfang Hospital of Southern Medical University.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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);
- Have a history of other malignant tumors, except for fully treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ;
- 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;
- 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.
- BMI is less than 18 or more than 25. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomics technology and liquid biopsyusing 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 | Diagnostic test | EBV virus infector, Healthy people, nasopharyngeal carcinoma patients |
Primary outcome
Achieve the expected number of enrolled cases
Time frame: 3 years
Achieve the expected number of enrolled cases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 38520712Zhou Z, Tang T, Li N, Zheng Q, Xiao T, Tian Y, Sun J, Zhang L, Wang X, Wang Y, Ye F, Chen Z, Zhang H, Zheng X, Cai Z, Liu L, Guan J. VLDL and LDL Subfractions Enhance the Risk Stratification of Individuals Who Underwent Epstein-Barr Virus-Based Screening for Nasopharyngeal Carcinoma: A Multicenter Cohort Study. Adv Sci (Weinh). 2024 Jun;11(22):e2308765. doi: 10.1002/advs.202308765. Epub 2024 Mar 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jian guan, MD principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and EBV Infection, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jian guan, MD (136 3210 2247, guanjian5461@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieve the expected number of enrolled cases (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05682703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.