A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949749
• Other study ID #: SYSKY-2023-631-01
• Status: Recruiting
• Start date: August 25, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Xiang-Wei Kong, Ph.D.
• Phone: 0086-020-34071439
• Email: sorahick[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma

Intervention

Diagnostic Test:
• Epitope exploration
Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline