TEMPUS PHOENIX HNSCC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Tempus AI
- 入组人数
- 500
- 试验地点
- 44
- 主要终点
- Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.
研究概览
简要总结
The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Willing and able to provide informed consent
- •Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
- •Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
- •Must submit tumor tissue sample representative of current disease per laboratory manual
排除标准
- •Non-squamous histologies (eg, nasopharynx or salivary gland)
- •Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
- •Tumors that are PD-L1 negative (CPS <1)
- •Clinical evidence of an active second invasive malignancy within <2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers
- •Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)
研究组 & 干预措施
Metastatic or unresectable recurrent HNSCC
Up to 500 participants (including primary tumor location of pharynx, larynx, oral cavity and oropharynx) with metastatic or unresectable recurrent HNSCC who are intended for first line immunotherapy or combination therapy. No intervention.
结局指标
主要结局
Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.
时间窗: 5 years
Use NGS, ctNDA assessments, RNA analysis, and other multiomic testing to uncover biomarkers of collected blood and tissue samples that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.
次要结局
- Explore changes in relevant DNA, RNA, immune and multiomic biomarkers in longitudinal blood samples, and diagnostic and progression biopsy samples, to understand real-world outcomes and resistance mechanisms.(5 years)
- Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker.(5 years)