Circulating HPV DNA for Post-treatment Surveillance in HPV-positive 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
- 150
- 试验地点
- 2
- 主要终点
- Recurrent disease Rate
研究概览
简要总结
In this research study the investigators are examining a blood test to detect HPV DNA in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.
详细描述
This research study involves blood tests to detect HPV DNA at regular time points after treatment for HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC). Participants may undergo scans based on the results of the blood tests. Study participants will also be asked to complete quality of life questionnaires periodically.
Participation in this study may last for up to 3 years. It is expected that about 150 people will take part in this research study.
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
- •Participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk HPV testing is positive on the involved node)
- •HPV-associated tumor as defined by one or more : positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods
- •Age 18 years or older
- •Will undergo oropharyngeal cancer treatment with curative intent
- •Ability to understand and the willingness to sign a written informed consent document.
- •Baseline positive or detectable ctHPV DNA result in plasma OR detectable corresponding HPV DNA in tumor tissue prior to treatment
排除标准
- •Distant metastatic disease (M1, AJCC 8th edition)
结局指标
主要结局
Recurrent disease Rate
时间窗: Up to 5 years
The proportion of patients with recurrence first detected by ctHPV DNA will be calculated as a percentage and 95% confidence intervals (CI) established using binomial exact calculation.
次要结局
- Recurrence Detection Predictive Properties(Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years)
- Time to diagnosis of recurrence(Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years)
- Progression-free survival (PFS)(Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years)
- Overall survival (OS)(Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years)
- Quality of Life (QOL)(Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years)
- Cost Comparison(Up to 5 years)
研究者
Eleni Marie Rettig, MD
Principal Investigator
Dana-Farber Cancer Institute