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

NCT05949749 | Unknown

• 1 other identifier: SYSKY-2023-631-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Case

Diagnostic Test: Epitope exploration

Control

Diagnostic Test: Epitope exploration

Interventions

Epitope exploration DIAGNOSTIC_TEST

Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.

Case; Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Xiao-Ming Huang, M.D.

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang-Wei Kong, Ph.D.

CONTACT

0086-020-34071439; sorahick@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 18, 2023
• Study Start: August 25, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 30, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

CN (1)