Screening for Early Diagnosis of Nose Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 2
- 主要终点
- Stage distribution of NPC
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of screening in identifying nasopharyngeal cancer (NPC), and evaluate the performance of Epstein-Barr virus (EBV) biomarkers in a community screening setting in Singapore.
Participants will assessed for their risk of NPC using EBV Early Antigen (EA) IgA serology and cell-free plasma EBV DNA. If the initial plasma EBV DNA test is positive, a repeat blood sample will be taken and tested. Saliva will also be collected for evaluation of EBV risk strains, but not used for risk evaluation.
- High risk individuals are determined by:
- a positive EBV EA IgA serology test, and/or
- two consecutive positive plasma EBV DNA tests
High risk individuals will undergo evaluation in the outpatient Otolaryngology clinic. The evaluation includes a head and neck examination, nasoendoscopy and nasopharyngeal biopsy. Clinical data will be collected at yearly intervals, for at least 3 years, with annual clinical examination and blood tests. 2. Low risk individuals are determined by:
- a negative EBV EA IgA serology, and
- a negative plasma EBV DNA test, or an initially positive plasma EBV DNA test followed by a negative plasma EBV DNA test on repeat blood taking.
Low risk individuals will be contacted via phone call every year for at least 3 years to confirm their disease status. Records will also be reviewed at the National Registry of Disease Office, Health Promotion Board, to confirm that the participant has not been diagnosed with nasopharyngeal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
Laboratories performing the EBV EA IgA serology and plasma EBV DNA are blinded to the clinical outcome of the participants.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese, Malay, and mixed ethnicities
- •individuals not diagnosed with NPC
- •individuals with family history of NPC
排除标准
- •younger than 35, older than 60
- •individuals already diagnosed with NPC
- •pregnant women
研究组 & 干预措施
High Risk Individuals
High risk individuals are determined by:
a positive EBV EA IgA serology test, and/or two consecutive positive plasma EBV DNA tests
High risk individuals will undergo evaluation in the outpatient Otolaryngology clinic. The evaluation includes a head and neck examination, nasoendoscopy and nasopharyngeal biopsy. Clinical data will be collected at yearly intervals, for at least 3 years, with annual clinical examination and blood tests.
干预措施: EBV biomarker testing (Diagnostic Test)
Low Risk Individuals
Low risk individuals are determined by: a negative EBV EA IgA serology, and negative plasma EBV DNA test (i.e. a negative plasma EBV DNA test, or an initially positive plasma EBV DNA test followed by a negative plasma EBV DNA test on repeat blood taking).
Low risk individuals will be contacted via phone call every year for at least 3 years to confirm their disease status. Records will also be reviewed at the National Registry of Disease Office, to confirm that the participant has not been diagnosed with NPC.
干预措施: EBV biomarker testing (Diagnostic Test)
结局指标
主要结局
Stage distribution of NPC
时间窗: From enrollment of the participant to follow-up at three years
Stage distribution of NPC diagnosed in study participants, compared to stage distribution of NPC in unscreened individuals routinely diagnosed in the clinic.
Accuracy of EBV IgA serology in identifying NPC cases
时间窗: From enrollment of the participant to follow-up at three years
Accuracy of EBV IgA serology including sensitivity, specificity, positive predictive value and negative predictive value
Accuracy of plasma EBV DNA in identifying NPC cases
时间窗: From enrollment of the participant to follow-up at three years
Accuracy of plasma EBV DNA including sensitivity, specificity, positive predictive value and negative predictive value
次要结局
未报告次要终点