LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- Recurrence of OPSCC
研究概览
简要总结
The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations.
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
- •≥ 18 years of age
- •T0-T2 N2a-N3 M0 or T3-T4 N0-N3 M0 (AJCC 7th edition)
- •Biopsy proven squamous cell carcinoma of the oropharynx or unknown primary
- •No prior therapy
- •No evidence of distant metastatic disease
- •p16 positive = diffuse ≥ 70% tumor cell expression, with at least moderate (2/3+) staining intensity
- •Planned for receipt of definitive cancer treatment
- •ECOG Performance Status 0-1
- •Patients must be deemed able to comply with the treatment plan and follow-up schedule.
- •Patients must provide study specific informed consent prior to study entry
排除标准
- •All subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:
- •Prior history of radiation therapy to the head and neck
- •Prior history of head and neck cancer.
- •Inadequate pre-treatment tissue sample for tumor genomic analyses
研究组 & 干预措施
HPV+ OPSCC Patients
Patients with p16+ squamous cell carcinoma of the oropharynx (or unknown primary) who will receive definitive cancer treatment.
结局指标
主要结局
Recurrence of OPSCC
时间窗: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years
Patients will undergo post-treatment CT scans per institutional standard of care to detect cancer recurrence. Status of recurrence of OPSCC will be confirmed based on biopsy.
Positive Predictive Value
时间窗: Baseline to up to 5 years
Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period.
Progression-free survival
时间窗: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years
Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date.
Negative Predictive Value
时间窗: Baseline to up to 5 years
Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.
Quality of Life questionnaire
时间窗: Baseline until recurrence or up to 5 years
At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment.
次要结局
未报告次要终点