A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Dominant gp42-IgG epitopes in cases
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Dominant gp42-IgG epitopes in cases
时间窗: Baseline
Dominant gp42-IgG epitopes revealed by ELISA with non-competitive monoclonal humanized antibodies against gp42 will be compared between cases and controls.
次要结局
未报告次要终点