Analysis of HPV DNA in Plasma in Patients With HPV-positive Oropharyngeal Squamous Cell Carcinoma - a Prospective Study of HPV DNA Levels for Treatment Response and Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The sensitivity of detectable ctHPVDNA one month after (c)RT completion
研究概览
简要总结
The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV.
The main question to answer is if the presence of HPV DNA in the blood one month after the treatment is useful in detecting remaining tumour or relapse within two years after treatment.
The participants will be asked to provide blood tests:
- before treatment
- weekly during the treatment
- on all scheduled follow-up appointments
- on all unplanned appointments where a relapse is suspected
详细描述
Background:
There is a yearly increase in the incidence of oropharyngeal carcinoma (OPC) of appr. 5% in Sweden, predominantly in males. More than 80% of the tumours are HPV (human papilloma virus)-positive. For that reason, measuring circulating tumour HPV DNA (ctHPVDNA) in plasma as a marker of treatment response and as an adjunct in surveillance has become an appealing possibility.
In Sweden, patients intended for curative treatment for OPC are usually treated with (chemo)radiotherapy (c)RT. A small proportion is subjected to surgery with or without adjuvant radiation. The gold standard for treatment evaluation after definitive (c)RT is a positron emission tomography-computed tomography (PET-CT) performed 12 weeks after (c)RT completion. The PET-CT result is most important to determine the need for neck dissection in patients with node-positive disease at diagnosis.
According to previous publications on the subject of ctHPVDNA, there are the following reasons to further explore the value of ctHPVDNA in routine clinical practice in patients with HPV-positive OPC:
- ctHPVDNA might limit or almost distinguish the issue with PET-CT results assessed as equivocal treatment evaluation response. A combination of the PET-CT result and ctHPVDNA analysis seems to increase the accuracy.
- ctHPVDNA has a great potential to detect recurrences before subjective symptoms occur and before it becomes apparent on clinical examination. Early detection of distant metastases in this group of patients might be valuable, since they have the potential for prolonged overall survival after salvage therapy compared to HPV-negative patients. And detection of a small tumour burden might improve survival further.
- An accurate detection of recurrences with ctHPVDNA in plasma might lead to a discussion of reducing scheduled follow-up appointments and following the patients with plasma samples instead.
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
- •Only patients with an HPV-positive primary tumour will eventually be eligible for inclusion.
- •Non-detectable ctHPVDNA at diagnosis will not be a reason for exclusion.
- •Age >18 years.
- •Able to give informed consent.
- •The patient will be treated with curative intent.
排除标准
- •Patients with a short life expectancy, psychiatric or addictive disorders, or other medical conditions which might impair patient compliance may be excluded at the discretion of the investigator.
结局指标
主要结局
The sensitivity of detectable ctHPVDNA one month after (c)RT completion
时间窗: From inclusion to two years after treatment
To determine if detectable ctHPVDNA one month post (C)RT is useful to detect residual or recurrent tumours diagnosed within two years.
次要结局
未报告次要终点