Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.
研究概览
简要总结
Prospective study to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for molecular profiling.
详细描述
In this prospective study the aim is to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs). Eligible population includes: NETs and PanNETs patients who have undergone or are undergoing treatment with targeted therapies and have shown prolonged clinical benefit, and NETs and PanNETs patients who have been treated with these agents and just recently progressed. RNA and DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to transcriptome sequencing and DNA sequencing analyses to evaluate possible genes of interest and related targetable pathways. Moreover, archived tumor samples will be requested from all patients to perform additional genomic testing. Remaining RNA and DNA will be banked for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).
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
- •Age > 18 years.
- •Histological or cytological proof of NETs or PanNETs.
- •At least one biopsiable lesion deemed medically accessible and safe to biopsy.
- •Current/recent treatment with targeted therapies with confirmed clinical benefit; confirmed progression disease to targeted therapies at the time of study enrollment.
- •Fulfills local institution's laboratory parameters for tumor biopsy.
- •Willingness and ability of patient to provide signed voluntary informed consent.
排除标准
- •Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
- •Any contraindication to undergoing a biopsy or blood collection procedure.
结局指标
主要结局
To prospectively collect tumor tissue and blood sample from patients with carcinoid tumors and islet cell tumors.
时间窗: 3 years
次要结局
- To evaluate gene alterations differences between carcinoid tumors and islet cell tumors.(3 years)
- To bank remaining samples for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).(3 years)
- To correlate genomic findings with treatment and clinical outcome.(3 years)
- To compare acquired data with existent available databases of whole genome or exome of neuroendocrine tumors(3 years)