Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04488263 |
| Other study ID # |
200139 |
| Secondary ID |
20-C-0139 |
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 24, 2020 |
| Est. completion date |
January 11, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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:
- 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:
- 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.
