Neuroendocrine TumorsNCT04488263
Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NEN)s
An observational study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 11 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary clinical
Who may be able to join
- Enrollment into NCI protocol 19C0016 'Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors'.
- Age greater than or equal to 3 years old
- Ability of subject or parent/guardian to understand and the willingness to sign a written consent document.
- Subjects with:
- --histologically or cytologically documented NENs, OR
- biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon, anterior pituitary hormones, OR
- Suspicion of NEN (from any site/origin) on axial imaging (CT/MRI/FDG, PET/68Ga-DOTATATE scan, FDOPA PET scan).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NENs)
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.
Read more
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.
Read the detailed 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.
- Conditions
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
- Keywords
- Clinical Outcome, Advice in the Management of Cancer, Patterns of Disease Progression, Response or Lack of Response to Therapeutic Interventions, Natural History
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects with confirmed/suspected NENs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
natural history of neuroendocrine neoplasms
clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start24 Nov 2020
- Primary completion6 Sep 2022
- Study completion11 Jan 2023
Why it stopped: To avoid the duplication of effort and resources associated with the PI's branch change.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jaydira Del Rivero, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488263
- Sponsor's protocol ID
- 200139
- Other IDs
- 20-C-0139
- Status last verified
- Jan 2023
- First submitted
- 24 Jul 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NENs)
- ClinicalTrials.gov ID
- NCT04488263
- Acronym / sponsor ID
- 200139
- Conditions
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
- Keywords
- Clinical Outcome, Advice in the Management of Cancer, Patterns of Disease Progression, Response or Lack of Response to Therapeutic Interventions, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: To avoid the duplication of effort and resources associated with the PI's branch change.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Subjects with confirmed/suspected NENs. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (7 listed)
- Enrollment into NCI protocol 19C0016 'Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors'.
- Age greater than or equal to 3 years old
- Ability of subject or parent/guardian to understand and the willingness to sign a written consent document.
- Subjects with:
- --histologically or cytologically documented NENs, OR
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
natural history of neuroendocrine neoplasms
Time frame: ongoing
clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival
Results and safety
The study was stopped early (reason given: To avoid the duplication of effort and resources associated with the PI's branch change.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaydira Del Rivero, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Carcinoma, Neuroendocrine, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: To avoid the duplication of effort and resources associated with the PI's branch change.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
natural history of neuroendocrine neoplasms (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.