COMETH Study: Comprehensive Oncogenomic Mapping and Exploration in Thoracic and Head & Neck Oncology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Establish a comprehensive blood and tissue biobank
研究概览
简要总结
This is an ancillary laboratory study to collect and bank blood and tissue samples. The biospecimens collected for this study will be invaluable for future research into predictive biomarkers and genomic alterations and their correlation with clinical outcomes.
详细描述
The goal of this study is to advance the research into the mechanism of resistance and genomic evaulation during therapy, serial blood samples will be collected from patients with advanced-stage non-small cell lung cancer, extensive-stage small cell lung cancer, metastatic squamous cell carcinoma of the head and neck, and malignant pleural mesothelioma who are inititating immunotherapy, with or without chemotherapy.
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
- •Ability of participant to understand this study, and participant willingness to sign a written informed consent. NOTE: Remote consenting allowed per IRB policy.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Males and/or females age ≥ 18 years
- •Diagnosis of one of the following:
- •Advanced stage (IIIB to IV) non-small cell lung cancer (all types including mixed histology, without actionable mutations)
- •Extensive-stage small cell lung cancer that are treatment naïve that will receive immunotherapy and chemotherapy
- •Recurrent or metastaƟc squamous cell head and neck cancers, squamous cell, HPV posiƟve or HPV negaƟve, treatment naïve that will start immunotherapy and chemotherapy
- •Malignant pleural mesothelioma that will be treated with immunotherapy and chemotherapy
- •Eligible to receive chemotherapy (plaƟnum based) with an immune checkpoint inhibitor (single or double agents).
- •Able to provide consent to obtain a blood sample, prior future genomic research of their samples.
- •Planning to start therapy in the next 28 days.
排除标准
- •Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- •Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation.
- •Advanced stage (IIIB to IV) non-small cell lung cancer with actionable mutations
- •Active viral infection (Hep C or B) requiring anti-viral therapy in the last 28 days. HIV patients on stable on anti-viral therapy able to receive therapy for the cancer are eligible to participate.
- •Active use of prednisone equivalent to more than 10mg/day
- •Second malignancy that requires systemic treatment at the time of consent
研究组 & 干预措施
Stage IIIB, IIIC or IV Non-small cell lung cancer
Participants with non-small cell lung cancer.
干预措施: Blood and Tissue Collection (Other)
Extensive-stage Small-cell lung cancer
Participants with extensive stage small-cell lung cancer.
干预措施: Blood and Tissue Collection (Other)
Metastatic squamous cell Head and Neck cancer
Participants with metastatic squamous-cell head and neck cancer.
干预措施: Blood and Tissue Collection (Other)
Malignant Pleural Mesothelioma
Participants with advanced malignant pleural mesothelioma.
干预措施: Blood and Tissue Collection (Other)
结局指标
主要结局
Establish a comprehensive blood and tissue biobank
时间窗: Samples will be collected at baseline (prior to treatment), over four cycles of therapy, at six months, and at disease progression; total participant duration minimum of 1 year
To establish a comprehensive blood and tissue biobank from patients with advanced-stage non-small cell and extensive-stage small cell lung, metastatic squamous cell head and neck cancer and malignant pleural mesothelioma who are initiating first-line chemo-immunotherapy, with the goal of supporting future genomic research.
次要结局
未报告次要终点
研究者
Chao Huang
Professor
University of Kansas Medical Center