Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
时间窗: 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.
次要结局
- Change From Baseline in HPV16 Viral Load in Plasma, Oral Swabs, and Oral Rinses(Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.)