Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NENs)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- natural history of neuroendocrine neoplasms
研究概览
简要总结
Background:
Neuroendocrine neoplasms (NENs) are rare tumors that originate in neuroendocrine cells. NENs can affect almost any part of the body. People with low-grade tumors can live many years. But high-grade tumors can be very aggressive. Researchers want to learn more about this type of cancer. This may help them design better treatments and supportive care studies.
Objective:
To gain a better understanding of neuroendocrine neoplasms.
Eligibility:
People starting at age 3 and older who have or are suspected of having NENs and are enrolled in protocol 19C0016, Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors
Design:
Participants will be screened with questions about their medical history. This may be done over the telephone or in person.
Participants medical records, test results, and imaging results will be reviewed. They may have scans and blood tests. They may sign a separate consent form for some of the tests.
Participants will complete paper or electronic surveys. The surveys will ask about the effects of cancer on their wellbeing.
Participants may give samples of their tumors from previous surgeries or biopsies. These samples will be used to study their tumor genes.
Participants will get advice on how to manage their NENs. They will also get recommendations about potential treatment options.
Participants home doctors will be contacted every 6 to 12 months. They will give medical data such as imaging and test results.
Participants may have follow-up visits at NIH every 6 to 12 months.
Participants will contact researchers if there are any changes in their tumor.
Participants will be followed on this study for life.
详细描述
Background:
- Neuroendocrine neoplasm (NENs) are divided into neuroendocrine tumors (NETs) and neuroendocrine carcinomas (NECs). These are rare malignancies occurring for example in the gastrointestinal tract, islets of the pancreas, lung, adrenal medulla, thyroid C-cells, etc. and are heterogeneous group of neoplasms with unique tumor biology, natural history, and clinical management issues.
- Their incidence has increased over the last decade, with an incidence of 6 per 100,000 persons a year and they represent 0.46% of all malignancies.
- Most NETs are sporadic, but they can be part of familial cancer syndromes such as multiple endocrine neoplasia type 1 (MEN1), neurofibromatosis type 1 (NF1) or Von Hippel- Lindau (VHL) syndrome. Whereas poorly differentiated neuroendocrine carcinomas (NECs) are all high-grade carcinomas that resemble small cell carcinoma or large cell carcinoma of the lung.
- Treatment for localized NETs is surgical resection, however, a variety of therapeutic options are available for patients with advanced NETs. When to apply a given option, what combination therapeutic approach should be used, how long treatment should be continued should be used is unclear and controversial.
Objective:
-Characterize the natural history of neuroendocrine neoplasms (NENs). Data will include clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival.
Eligibility:
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
natural history of neuroendocrine neoplasms
时间窗: ongoing
clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival
次要结局
未报告次要终点