NCT06592716进行中（未招募）不适用
Specificity and Sensitivity of Circulating HPV-DNA in Patients With Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of HPV ddPCR
研究概览
简要总结
This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
- •Above 18 years of age
- •Informed consent
排除标准
- •The patient does not speak or understand Danish
- •patients recieving palliative treatment
结局指标
主要结局
Sensitivity and specificity of HPV ddPCR
时间窗: At enrollment and at 2 months after end treatment, and hereafter every 6 month for a minimum of 2 years, up to 3 years, or at suspicion of recurrence.
Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence.
次要结局
- Time to recurrence by ctHPV-DNA(From enrollment and for minimum 2 years, up to 3 years, after treatment)
- Time to recurrence by clinical/radiological examination(From enrollment and for minimum 2 years, up to 3 years, after treatment)
- PET/CT(From enrollment and for minimum 2 years, up to 3 years, after treatment)
- Cancer fast-track referrals(From enrollment and for minimum 2 years, up to 3 years, after treatment)
- Fear of Recurrence Questionnaire(at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years)
研究者
Christian Grønhøj Larsen
Senior Registrar, PhD, DMSci, Assistant Professor
Rigshospitalet, Denmark
研究点 (1)
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