Multi-Omic Assessment of Squamous Cell Cancers Receiving Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Characterization of Genomic, epigenetic and Immune Profiling Features
研究概览
简要总结
This is prospective research study which will include patients with recurrent or metastatic squamous cell carcinoma of the head and neck, esophagus and anal canal starting on first-line platinum based chemotherapy or any line of immunotherapy treatment.This study aims to characterize the dynamic changes in genomic, epigenetic, immune profiling and imaging data during treatment with systemic therapy. Patients will have archived tumor samples requested as well as blood samples collected at up to four time points to analyze these changes. Imaging data will be derived from patients' routine CT scans before and after treatment.
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 a histological or cytological diagnosis of Squamous Cell Cancer of the head and neck, esophagus or anal canal who have radiologically confirmed recurrent or metastatic disease.
- •Patients must be of adequate fitness, ECOG 0-1 for systemic therapy, with either standard chemotherapy, immunotherapy or within the context of a clinical trial.
- •Patients must be commencing on a new treatment at time of consent, this can be first line platinum based chemotherapy, or immunotherapy, any line.
- •Patients must be ≥ 18 years old.
- •Patients must have provided voluntary written informed consent.
排除标准
- 未提供
研究组 & 干预措施
MASST
Patients with a histological or cytological confirmed diagnosis of Squamous Cell Cancer of the Head & Neck, Esophagus or Anal Canal who have radiologically confirmed recurrent or metastatic disease and are commencing on a new treatment or either first-line platinum based chemotherapy or any line immunotherapy.
结局指标
主要结局
Characterization of Genomic, epigenetic and Immune Profiling Features
时间窗: Through study completion, up to 4 years
To comprehensively characterize genomic, epigenetic and immune profiling features and changes in longitudinal blood samples that are associated with systemic treatment of recurrent or metastatic squamous cell cancers of the head \& neck, esophagus and anal canal.
次要结局
- Establish a Clinically Annotated Biorepository(Through study completion, up to 4 years)
- Correlate Multi-Omic Results with Clinical Outcome(Through study completion, up to 4 years)
- Compare HPV-Positive and HPV-Negative Cell Histologies(Through study completion, up to 4 years)
- Investigate the Relationship Between Genomic Profiles and Radiomic Signatures(Through study completion, up to 4 years)
- Enable Data-Sharing(Though study completion, up to 4 years)