NCT02881918Unknown不适用
Anti-tumor Specific Immune Response in Head and Neck Cancers
Central Hospital, Nancy, France6 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2017年3月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 154
- 试验地点
- 6
- 主要终点
- Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage
研究概览
简要总结
The purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head & Neck Squamous Cell Carcinoma
Secondary purposes are:
- Study of relationship between anti-tumor immune response and qualitative (yes/no) and quantitative (number) presence of circulating tumor cells (CTCs);
- Study of relationship between qualitative (yes/no) and quantitative (number) presence of CTCs and clinical stage as well as DFS
- Study of relationship between anti-tumor immune response and clinical stage as well as DFS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patient with Head & Neck Squamous Cell Carcinoma after extension assessment, regardless of clinical stage (TNM UICC stage I-IV), before any medical or surgical treatment specifically directed against cancer (radiotherapy, surgery, chemotherapy or targeted therapy)
- •Consent to participate to the study, non-opposition
- •Affiliation to social security
排除标准
- •History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy
- •HIV infection
- •Corticotherapy during 15 days before blood sampling
结局指标
主要结局
Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage
时间窗: day 0
次要结局
- Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis(2 years after diagnosis)
- Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage(day 0)
- Number of CTCs according to tumor stage(day 0)
- Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA(2 years after diagnosis)
- Polyfunctionality index of lymphocytes according to number of CTCs(day 0)
研究者
研究点 (6)
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