Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NEN)s
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- STATUS
- Recruiting
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- End date
- Dec 31, 2028
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- participants needed
- 300
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- sponsor
- National Cancer Institute (NCI)
Summary
- 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.
Description
- Background
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- 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
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- Subjects with confirmed or suspicion of NENs.
- Age greater than or equal to 3 years old
- Design
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- This protocol is a subprotocol of protocol 19C0016 Natural History and Biospecimen Accrual Study for Children and Adults with Rare Solid Tumors . After enrollment on the master protocol and undergoing evaluations detailed in the master protocol, patients will be enrolled on this subprotocol specific for NENs.
- Medical histories will be documented, and patients followed throughout the course of their illnesses, with particular attention to patterns of disease recurrence and progression, response to therapies, duration of responses and hormone production in patients with hormone production as a manifestation of their disease. Tumor growth rates will also be calculated throughout the course of the disease.
Details
| Condition | Neuroendocrine Tumor, Neuroectodermal Tumor, neurectoderma, Neuroendocrine carcinoma, Neuroendocrine carcinoma, neurectoderma |
|---|---|
| Age | 3-100 years |
| Clinical Study Identifier | NCT04488263 |
| Sponsor | National Cancer Institute (NCI) |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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