Characterisation of the Immune Infiltrate and Molecular Features of Thymic Epithelial Tumors Tumors (TETs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Somatic molecular characterisation of TETs
研究概览
简要总结
The IMMUNO-TET trial aims to assess the feasibility of characterising the immune environment of TETs and the constitutional and somatic molecular profiles of patients with localised thymic epithelial tumour (TET).
详细描述
In this prospective study, patients undergoing thymectomy and thymomectomy as part of routine care undergo the following care pathway:
- During the pre-surgical visit (for n = 50 patients): as part of routine care, a blood sample is collected for analysis of CBC, leukocytes, lymphocytes, CRP, ferritinemia, TSH, T3L, T4L, anti-acetycholine receptor antibodies, …CMV, EBV, HSV, HIV serologies, …and HLA class I and class II typing.
- During thymectomy and thymomectomy surgery, the following samples are taken (for n = 50 patients):
- 6 blood samples on EDTA tubes are collected at the time of surgery for analyses.
- 3 fresh samples of the surgical specimen are taken by the pathologist: tumour T, juxta-tumour J and distant D locations for analyses by flow cytometry and RNA sequencing. Anatomopathology blocks/slides are also cut in the same way (tumour T, juxta-tumour J and distant D locations) for additional exploratory analyses.
- The feasibility of developing patient-derived xenografts (PDX) from TETs will be tested for n = 20 tumor samples. These models will allow to test potential therapeutic agents for this pathology.
- During the 1st month (+/- 7 days) post-surgery check-up, a blood sample is taken again (for n = 50 patients) for routine care: CBC, leukocytes, lymphocytes, CRP, ferritinemia, anti-acetycholine receptor antibodies and for peripheral immune system analysis at a distance from surgery and for constitutional molecular analysis.
Informed consent is given to participate in this prospective study.
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
- •Patient with suspicion of localised thymic epithelial tumour.
- •Age ≥ 18 years.
- •Treatment-naïve patient for this disease.
- •Patient with an indication for thymectomy and thymomectomy in one of the partner centers.
- •Signed informed consent form of the patient.
排除标准
- •Neoadjuvant chemotherapy.
- •No social security affiliation.
- •Person under legal protection.
- •Other neoplasia in progress or cured within the last 3 years (except for operated carcinoma in situ).
研究组 & 干预措施
single arm for all patients
single arm for all patients tumor samples will be taken for RNA sequencing of epithelial tumour cells during surgery.
blood samples will be taken for Exome Sequencing (WES) at baseline, during surgery and one month post surgery.
干预措施: single arm for all patients (Other)
结局指标
主要结局
Somatic molecular characterisation of TETs
时间窗: 38 months
Description of genetic abnormalities in thymic tumours compared to non-tumourous thymic tissue (Whole Exome Sequencing RNA-sequencing technique, DNA Optical mapping);
Characterisation of the immune environment of TETs
时间窗: 38 months
Description of immune cells in the tumour environment, description of tumour infiltrating T cells
Establishment of a patient-derived xenograft mouse model.
时间窗: 38 months
Patient-derived xenograft mouse model established from thymic tumour.
Molecular characterisation of TETs
时间窗: 38 months
Molecular constitutional characterisation of TETs with the technique of the Exome Sequencing (WES) on blood samples of patients with TETs
次要结局
- Characterisation of potential alterations in signalling pathways to identify potential therapeutic targets(38 months)
- Identification of potential neoepitopes(38 months)
- Epigenetic characterisation of TETs(38 months)
- Genomic characterisation of TETs(38 months)
- Transcriptomic characterisation of TETs(38 months)