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Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC)

Study Purpose

Background: Neuroendocrine neoplasm (NENs)are rare cancers arising from the neuroendocrine cells and can affect almost any part of the body. They vary from low grade neuroendocrine tumors (NETs) to high grade neuroendocrine carcinomas (NECs). These tumors often occur in the gastrointestinal tract, pancreas, lungs, adrenal medulla (pheochromocytomas) or adrenal cortex (adrenocortical cancer) and other areas of the body mentioned below:

  • - Gastroenteropancreatic neuroendocrine tumors (GEP-NET): stomach, duodenum, pancreas, colon, appendix, etc. - Liver and gallbladder.
  • - Adrenal tumors.
  • - Pituitary gland.
  • - Thyroid gland: medullary thyroid carcinoma.
  • - Parathyroid tumors.
  • - Pulmonary neuroendocrine tumors: typical and atypical carcinoid, small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC) - Extrapulmonary small cell cancer.
  • - Peripheral nervous system tumors: paraganglioma, neuroblastoma) - Breast and genitourinary tract.
Their rates are rising in the United States and worldwide. Researchers want to learn more about NENs through this natural history study. Objective: To study the natural history of people with NENs and obtain samples from them to learn more about the disease. The clinical management of all NETs is not standardized, with only a few FDA-approved therapies and we would like to learn which combination therapeutic approach should be used, how long treatment should be continued, and in what subgroup of NENs a particular treatment option should be used. Eligibility: People aged 18 and older who have or are suspected to have NENs or ACC. Design: Participants will be screened with a medical history. Participants will have a physical exam. Their symptoms and their ability to perform their normal activities will be reviewed. They will have blood and urine tests. Participants will receive recommendations for managing their disease and potential treatment options. They will be able to ask as many questions as they would like. Participants may provide saliva, blood, and stool samples for research. They will give tumor samples from a previous surgery or biopsy. Participants may have optional biopsies. During biopsies, cancer tissue will be obtained using a needle and syringe. Tissue will be taken from the liver, lung, or a lymph node. Participants may have an imaging scan or ultrasound to help locate the tumor or area to be biopsied. They will receive local anesthesia and may be sedated. Participants will complete a questionnaire about their family medical history. Participants will have follow-up visits every 6 months. They will have physical exams and give samples. If their health changes, they may have extra visits. If they cannot visit NIH, they (or their doctor) will be contacted by phone or email. Participants will take part in the study for all their life.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

  • -

    INCLUSION CRITERIA:

    - Age >= 18 years old.
  • - The ability of the participant to understand and the willingness to sign a written consent document.
  • - Participants with the documentation of: - histological or cytological confirmation of NENs or adrenocortical cancer.
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-hydroxyindoleacetic acid (5-HIAA)), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, Cpeptide (proinsulin), glucagon, anterior pituitary hormones. OR. --Suspicion of NEN (from any site/origin) on axial imaging (computed tomography (CT)/ magnetic resonance imaging (MRI) / fluorodeoxyglucose (FDG) positron emission tomography (PET) / 68Ga-Dotatate scan. OR. --a germline genetic variant that predisposes to NETs including ACC.

EXCLUSION CRITERIA:

None

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05237934
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jaydira Del Rivero, M.D.
Principal Investigator Affiliation National Cancer Institute (NCI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Neuroendocrine Tumors, Carcinoma, Neuroendocrine
Study Website: View Trial Website
Additional Details

Background:

  • - Neuroendocrine neoplasms (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 is a heterogeneous group of neoplasms with unique tumor biology, natural history, and clinical management issues.
  • - The annual occurrence of NENs has been increasing in the United States (US) and worldwide.
The current incidence in the US is about 6 per 100,000 persons a year and represents 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.
Poorly differentiated NECs are all high-grade carcinomas that resemble small cell carcinoma or large cell NEC 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, and in what subgroup of patients a particular treatment option should be used is unclear and controversial. Objective: -To comprehensively and longitudinally evaluate the natural history of participants with NENs and allow sample acquisition for use in the study of NENs. Eligibility:
  • - Participants with confirmed or suspected NENs including ACC.
  • - Age >= 18 years old.
Design:
  • - This protocol is a bio-specimen collection and natural history protocol in which samples will be collected from participants with NENs (from well-differentiated to poorly differentiated neuroendocrine neoplasm).
  • - An accrual ceiling of 300 participants is planned over an accrual period of 10 years.

Arms & Interventions

Arms

: Cohort 1

Participants with confirmed/suspected NENs including ACC

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

sarah.kelley@nih.gov

888-624-1937

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