A Feasibility Study to Identify T-cell Responses to Neo-epitopes in Tumor Invaded Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma and quantification of CD8+ T cells specific for the tumor neo-antigens identified in the lymph nodes.
研究概览
简要总结
Feasibility study for a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma, and quantification of CD8+ T cells specific for these tumor neo-antigens in their lymph nodes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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 over 18 years Patient with HR+ , HER2- and node-positive (proven by cytology) invasive ductal carcinoma breast cancer, grade (SBR) II or III, and having an axillary dissection programmed, Or patient having cutaneous melanoma scheduled for a lymph node dissection at the Institut Curie including dissection of the lymph nodes draining the tumor, Voluntary having signed and dated written informed consents prior to any specific study procedure,
排除标准
- •Patients treated for a breast cancer who received neoadjuvant chemotherapy Patients treated for breast cancer with distant metastases (M+)• Only for patients with breast cancer: oral or systemic corticosteroids treatment received within 30 days prior surgery Patients on immunosuppressive treatment or diagnosed of an immunodeficiency Patients with known chronic viral infection as HIV1 or 2, HBV, HCV Patients with other cancer diagnosed within 5 years (except squamous cell cutaneous carcinomas) Patients without a French social security Patients deprived of liberty or placed under the authority of a tutor
结局指标
主要结局
Feasibility of a method allowing identification of tumor mutated epitopes in patients with breast cancer or cutaneous melanoma and quantification of CD8+ T cells specific for the tumor neo-antigens identified in the lymph nodes.
时间窗: up to 24 months
Feasibility study for a method allowing identification of tumor mutated epitopes : Identification of MHC cl I and II restricted tumor neo-epitopes by two different methods i.e. by an elution-HPLC method performed on cell lines derived from tumor cells obtained from invaded lymph node, or using predictive algorithms on tumor sequencing data.
次要结局
- Quantification of CD4+ T lymphocytes specific for identified tumor neo-antigens in the lymph nodes.(up to 24 months)
- Comparison of the frequency and relative amplitude of the T cell response specific for the tumor neo-epitopes with other immune responses and responses against known tumor antigens.(up to 24 months)
- Quantification of CD4+ and CD8+ T lymphocytes specific for identified neo-antigens in the blood and tumor.(up to 24 months)