Nasopharyngeal CarcinomaNCT05949749
A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Epstein-barr virus (EBV) infection is a necessary factor of nasopharyngeal carcinoma (NPC). The incidence of NPC in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Epitope exploration
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 30 Sep 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Chinese.
Who may be able to join
- Controls underwent physical examinations or primary NPC cases confirmed by pathology or cytology.
- If cases, at stage I-IVB diagnosed by radiology according to AJCC/UICC 8th.
- If cases, Karnofsky score (KFS)≥70, estimated survival span>12 months.
- If cases, no disordered of major organs is found; blood test, liver, and kidney functions are basically normal.
- If cases, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Who cannot join
- History of other malignant diseases.
- History of severe systemic diseases or heart, lung, liver, or kidney disfunction.
- History of severe neurological, metal, endocrine diseases.
- History of HBV, HCV, HIV, TP, or TB infection.
- If controls, physical examination reveals systemic diseases including malignant diseases.
- If cases, incomplete blood and pathological sample data.
- If cases, not receiving primary treatment in this facility.
- Other individuals investigators find not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Xiang-Wei Kong, Ph.D.
About this study
Epstein-barr virus (EBV) infection is a necessary factor of nasopharyngeal carcinoma (NPC). The incidence of NPC in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. However, no EBV prophylactic vaccines is clinically available so far, which is largely hampered by the difficulties in selecting optimal vaccine design target out of 13 glycoproteins on the surface of EBV. In this study, we utilized humanized gp42-IgG antibodies to explore the dominant epitopes of gp42, one of the functional EBV glycoproteins during virus entry, to facilitate prophylactic vaccine design.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Epitope exploration
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epitope explorationDiagnostic test
Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described Receives: Diagnostic Test: Epitope exploration | |
| Control | Not described Receives: Diagnostic Test: Epitope exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dominant gp42-IgG epitopes in cases
Dominant gp42-IgG epitopes revealed by ELISA with non-competitive monoclonal humanized antibodies against gp42 will be compared between cases and controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start25 Aug 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao-Ming Huang, M.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949749
- Sponsor's protocol ID
- SYSKY-2023-631-01
- Status last verified
- Sep 2023
- First submitted
- 21 Jun 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC
- ClinicalTrials.gov ID
- NCT05949749
- Acronym / sponsor ID
- SYSKY-2023-631-01
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Jul 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.
Epstein-barr virus (EBV) infection is a necessary factor of nasopharyngeal carcinoma (NPC). The incidence of NPC in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. However, no EBV prophylactic vaccines is clinically available so far, which is largely hampered by the difficulties in selecting optimal vaccine design target out of 13 glycoproteins on the surface of EBV. In this study, we utilized humanized gp42-IgG antibodies to explore the dominant epitopes of gp42, one of the functional EBV glycoproteins during virus entry, to facilitate prophylactic vaccine design.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Epitope exploration |
| Control | – | Diagnostic Test: Epitope exploration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese.
Key inclusion criteria (5 listed)
- Controls underwent physical examinations or primary NPC cases confirmed by pathology or cytology.
- If cases, at stage I-IVB diagnosed by radiology according to AJCC/UICC 8th.
- If cases, Karnofsky score (KFS)≥70, estimated survival span>12 months.
- If cases, no disordered of major organs is found; blood test, liver, and kidney functions are basically normal.
- If cases, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
Key exclusion criteria (8 listed)
- History of other malignant diseases.
- History of severe systemic diseases or heart, lung, liver, or kidney disfunction.
- History of severe neurological, metal, endocrine diseases.
- History of HBV, HCV, HIV, TP, or TB infection.
- If controls, physical examination reveals systemic diseases including malignant diseases.
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 |
|---|---|---|
| Epitope explorationExplore the epitope landscape of gp42-IgG of cases in comparison with that of controls. | Diagnostic test | Case, Control |
Primary outcome
Dominant gp42-IgG epitopes in cases
Time frame: Baseline
Dominant gp42-IgG epitopes revealed by ELISA with non-competitive monoclonal humanized antibodies against gp42 will be compared between cases and controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Xiao-Ming Huang, M.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 5 inclusion and 8 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 6 Sep 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 Xiang-Wei Kong, Ph.D. (0086-020-34071439, sorahick@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dominant gp42-IgG epitopes in cases (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2023.