用于早期检测 HPV 相关口咽癌的生物标志物筛查方法 (BASH OPC) (BASH OPC)
Investigators seek to determine the sensitivity and specificity of a combined HPV 16 DNA and host gene methylation oral biomarker panel to distinguish early Oropharyngeal Cancer (OPC) cases from controls among 100 early and 100 late disease pre-treatment OPC cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Kimberly Isaacs-Soriano
- 电话号码：813-745-6992
- 邮箱：kimberly.Isaacs-Soriano@moffitt.org
学习地点
-
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Florida
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Tampa、Florida、美国、33612
- 招聘中
- Moffitt Cancer Center
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副研究员：
- Christine Chung, MD
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接触：
- Kimberly Isaacs-Soriano
- 电话号码：813-745-6992
- 邮箱：kimberly.Isaacs-Soriano@moffitt.org
-
首席研究员：
- Anna Giuliano, PhD
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首席研究员：
- Antonio Amelio, PhD
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副研究员：
- Jimmy Caudell, MD, PhD
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副研究员：
- Bruce Wenig, MD
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Nebraska
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Omaha、Nebraska、美国、68198
- 招聘中
- University of Nebraska Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15232
- 招聘中
- University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
-
接触：
- Jose P. Zevallos, MD, PhD
- 邮箱：zevallosjp@upmc.edu
-
接触：
- Robert Ferris, PhD
- 邮箱：ferrrl@UPMC.EDU
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population will consist of 100 early and 100 late disease pre-treatment Oropharyngeal Cancer cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the Moffitt Cancer Center (Moffitt) and the University of Pittsburgh Medical Center Hillman Cancer Center (Pittsburgh).
描述
Inclusion Criteria:
Cases:
- Aged at least 18 years
- Newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages I-IV)
- Has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks
- Provided written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is identified and enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
- Aged at least 35 years
- Have no previous diagnosis of HNC or HPV-related cancer
- Fully understands study procedures
- Voluntarily agrees to participate by giving written informed consent under Moffitt Cancer Center (MCC) 17716 biomarker/biobanking study or is enrolled at the University of Pittsburgh Medical Center Hillman Cancer Center
Exclusion Criteria:
- Not meeting all of the above inclusion criteria for either the case or control group
学习计划
研究是如何设计的？
设计细节
- 观测模型：CASE_CONTROL
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Case Group
Case group will consist of early and late disease pre-treatment Oropharyngeal Cancer cases. |
DNA Methylation Profiling |
|
Control Group
Controls will be enrolled from members of the catchment area to ensure geographic comparability of cases and controls. Controls will be matched by sex, age, race/ethnicity, and tobacco use. |
DNA Methylation Profiling |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diagnostic Sensitivity
大体时间：Up to 60 months
|
A 95% one-sided confidence interval using the Wilson method will be obtained for sensitivity for the early Oropharyngeal Cancer cases and late Oropharyngeal Cancer cases. |
Up to 60 months
|
|
Diagnostic Specificity
大体时间：Up to 60 months
|
A 95% one-sided confidence interval using the Wilson method will be obtained for Specificity based on the control patients. |
Up to 60 months
|
合作者和调查者
调查人员
- 首席研究员：Anna Giuliano, PhD、Moffitt Cancer Center
- 首席研究员：Antonio Amelio, PhD、Moffitt Cancer Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.