Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NEN)s
-
- STATUS
- Recruiting
-
- End date
- Dec 31, 2028
-
- participants needed
- 300
-
- sponsor
- National Cancer Institute (NCI)
Summary
- Background
Neuroendocrine
- Objective
To gain a better understanding of neuroendocrine
- 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
- 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
Participants will complete paper or electronic surveys. The surveys will ask about the
effects of
Participants may give samples of their
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
Participants will be followed on this study for life.
Description
- Background
-
Neuroendocrine neoplasm (NENs) are divided intoneuroendocrine tumors (NETs) andneuroendocrine carcinomas (NECs). These are raremalignancies occurring for example in the gastrointestinal tract, islets of thepancreas , lung,adrenal medulla, thyroid C-cells, etc. and are heterogeneous group ofneoplasms with uniquetumor 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 asmultiple endocrine neoplasia type 1 (MEN1 ),neurofibromatosis type 1 (NF1) or Von Hippel- Lindau (VHL) syndrome. Whereas poorly differentiatedneuroendocrine carcinomas (NECs) are all high-gradecarcinomas that resemblesmall cell carcinoma or large cellcarcinoma 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
- Eligibility
-
- Subjects with confirmed or suspicion of NENs.
- Age greater than or equal to 3 years old
- Design
-
- 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.
- This protocol is a subprotocol of protocol 19C0016 Natural History and Biospecimen
Accrual Study for Children and Adults with Rare
Details
| Condition |
|
|---|---|
| Age | 3years - 100years |
| Clinical Study Identifier | NCT04488263 |
| Sponsor | National |
| 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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