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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05949749
Collaborator
(none)
1,000
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Epitope exploration

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Case

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

Control

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

Outcome Measures

Primary Outcome Measures

  1. Dominant gp42-IgG epitopes in cases [Baseline]

    Dominant gp42-IgG epitopes revealed by ELISA with non-competitive monoclonal humanized antibodies against gp42 will be compared between cases and controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Xiao-Ming Huang, M.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05949749
Other Study ID Numbers:
  • SYSKY-2023-631-01
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023