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

September 4, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiang-Wei Kong, Ph.D.
  • Phone Number: 0086-020-34071439
  • Email: sorahick@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-Sen Memorial Hospital
        • Contact:
          • Xiang-Wei Kong, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Chinese.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Diagnostic test: Epitope exploration
Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.
Case
Diagnostic test: Epitope exploration
Explore the epitope landscape of gp42-IgG of cases in comparison with that of controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2023-631-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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