Natural History Study of Children and Adults With Neuroendocrine Neoplasms (NEN)s

NCT04488263 | Terminated

• 2 other identifiers: 20013920-C-0139
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• natural history of neuroendocrine neoplasms

  clinical presentation, patterns of disease progression, response or lack of response to therapeutic interventions, disease recurrence and overall survival

  ongoing

Study Arms (1)

Cohort 1

Subjects with confirmed/suspected NENs.

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary clinical

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Jaydira Del Rivero, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 27, 2020
• Study Start: November 24, 2020
• Primary Completion: September 6, 2022
• Study Completion: January 11, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

US (1)