A Registry for Neuroendocrine Tumors
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Tumor-related recurrence or progression
研究概览
简要总结
Neuroendocrine tumors are derived from the neuroendocrine system of the gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery, medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at collecting data and blood samples from patients presenting with a NET. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry through prospective agreements and sub-study protocols with Wren Laboratories. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.
详细描述
Background: Survival for neuroendocrine tumors is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. Non-invasive biomarkers have been identified that can improve diagnosis and prognosis of patients. Little, however, is known about the utility of these markers in clinical practice.
Objective: To systematically and prospectively collect clinical information and blood samples for NETest from neuroendocrine tumors to evaluate the clinical validity of this biomarker for diagnosis, surveillance, and prediction of disease prognosis and response to targeted therapeutics.
Methods: All neuroendocrine tumors (gastroenteropancreatic and pulmonary) are following informed consent. Data will be entered prospectively and anonymized. Patient history including a quality of life survey are completed by contributing physicians and blood sample is collected for analysis. All information will be transferred to the database. Evaluation of treatment modalities and patient outcomes (e.g. disease recurrence) will be assessed at follow-up times.
The primary objectives of the project are to:
- monitor patients with neuroendocrine tumors
- provide descriptive statistical analyses
- assessment of diagnostic accuracy of NETest
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
- 是
入选标准
- •Gastroenteropancreatic neuroendocrine tumor
- •Bronchopulmonary neuroendocrine tumor
- •Gastroenteropancreatic neuroendocrine carcinoma
- •Pre- and post-surgical patients
- •Watch & Wait/no treatment
- •Treatment including somatostatin analogues, PRRT, targeted therapies.
- •Patient provides informed consent
排除标准
- 未提供
结局指标
主要结局
Tumor-related recurrence or progression
时间窗: 5 years
Image-based identification of recurrent or progressive tumor disease
Tumor-related diagnosis
时间窗: 1 year
Histological confirmation of neuroendocrine tumor
Tumor-related mortality
时间窗: 10 years
Survival from disease
次要结局
- Quality of Life Evaluation(5 years)
- Biomarker prediction of treatment response and disease relapse(10 years)