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HPV-associated Oropharyngeal Carcinoma (HPV-OPC) (HPV-OPC)

2026年7月17日 更新者：Masaryk Memorial Cancer Institute

Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers

This study focuses on the longitudinal monitoring of HPV infection in patients with head and neck cancers, particularly oropharyngeal carcinoma (OPC), using a new electrochemical detection method. This method has already been successfully developed and validated for cervical cancer. The aim of the project is to monitor the dynamics of HPV viral load before the start of treatment and during conservative radiation therapy or concurrent chemoradiation therapy. HPV will be analyzed from oral swabs, oral cavity washings, and plasma as part of a small prospective study. The results of the new method will be correlated with standard techniques, particularly qPCR. Longitudinal monitoring may contribute to the individualization and potential de-escalation of treatment in selected patients.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Patients with HPV-positive head and neck tumors, primarily OPC, who are indicated for conservative radiation therapy or concurrent chemoradiation therapy will be enrolled in the study. At defined time points (before the start of treatment and during treatment), oral swabs, oral cavity washings, and peripheral blood samples will be collected, from which plasma will be isolated for analysis of viral ctDNA. We estimate approximately 20 patients with OPC indicated for radiotherapy alone or concurrent chemoradiotherapy who are p16-positive. Negative controls will be patients with OPC indicated for radiotherapy alone or concurrent chemoradiotherapy who are p16-negative (approximately 10-15).

研究类型

介入性

注册 (估计的)

35

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 捷克语
    • Czech Republic
      • Brno、Czech Republic、捷克语、65653
        • 招聘中
        • Masaryk Memorial Cancer Institute
        • 接触：
        • 接触：
        • 首席研究员：
          • Tomáš Novotný, MUDr.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • a patient with an oropharyngeal tumor indicated for curative radiation therapy or chemoradiotherapy
  • if radiation therapy or chemoradiotherapy was preceded by surgery, the patient may be enrolled if the lesion persists on imaging studies
  • the lesion must be a histologically confirmed squamous cell carcinoma with known p16 status
  • age ≥ 18 years
  • the subject must be willing and able to provide written informed consent for specimen collection
  • ability to communicate effectively with the investigator in the local language, and ability to understand and comply with the study requirements

Exclusion Criteria:

  • previous induction chemotherapy
  • unknown p16 status, incomplete or inadequate histology-e.g., adenocarcinoma, melanoma, lymphoma,
  • previous radiation therapy to the oropharynx
  • palliative patients indicated for accelerated radiation therapy with a treatment duration of < 5.5 weeks
  • age < 18 years
  • pregnant or breastfeeding women
  • patients in the terminal stage of life
  • severe alcohol and/or drug abuse during treatment

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：p16 positive OPC patients
20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
诊断测试：HPV p16
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
其他名称：
  • oral swabs
  • oral cavity washings
  • peripheral blood samples
诊断测试：HPV testing - positive results
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
其他名称：
  • oral swabs
  • oral cavity washings
  • peripheral blood samples
有源比较器：p16 negative OPC patients
The negative controls will be patients with OPC who are indicated for radiotherapy alone or concomitant chemoradiotherapy and who are p16-negative (approximately 10-15).
诊断测试：HPV p16
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
其他名称：
  • oral swabs
  • oral cavity washings
  • peripheral blood samples
诊断测试：HPV testing - negative results
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients. We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity. By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
其他名称：
  • oral swabs
  • oral cavity washings
  • peripheral blood samples

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
Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
大体时间：Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy
Assessment of the diagnostic agreement between a novel electrochemical biosensor and the standard qPCR method for detecting HPV infection in patients with HPV-positive oropharyngeal cancer (OPC). Data will be reported as the correlation coefficient and sensitivity/specificity of the electrochemical method relative to the gold standard.
Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in HPV16 Viral Load in Plasma, Oral Swabs, and Oral Rinses
大体时间：Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.
Quantification of HPV16 DNA concentration (measured in copies/mL) across three distinct matrices: (a) circulating DNA extracted from plasma, (b) oral swabs, and (c) oral rinses. Measurements will be performed using both standard quantitative PCR (qPCR) and the new electrochemical biosensor to track viral clearance dynamics during and after treatment.
Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Masaryk Memorial Cancer Institute

调查人员

  • 首席研究员：Tomáš Novotný, MUDr.、Masaryk Memorial Cancer Institute

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月25日

初级完成 (估计的)

2027年3月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A6/26

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD to be shared in pseudonymized form during the study.IPD to be published in anonymized form.

IPD 共享时间框架

after study completion

IPD 共享访问标准

During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team.After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator.The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.

IPD 共享支持信息类型

  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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