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

NCT ID: NCT05949749

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-25

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Case

Epitope exploration

Intervention Type DIAGNOSTIC_TEST

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

Control

Epitope exploration

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Epitope exploration

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiao-Ming Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiang-Wei Kong, Ph.D.

Role: CONTACT

0086-020-34071439

Facility Contacts

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Xiang-Wei Kong, Ph.D.

Role: primary

Other Identifiers

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SYSKY-2023-631-01

Identifier Type: -

Identifier Source: org_study_id

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