NCT05237934 Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC)
| NCT ID | NCT05237934 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Neuroendocrine Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-04-25 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-04-25 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 and blood, a 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 12 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.
Eligibility 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
Contact & Investigator
Jaydira Del Rivero, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT05237934 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Neuroendocrine Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05237934 currently recruiting?
Yes, NCT05237934 is actively recruiting participants. Contact the research team at anna.rivero@nih.gov for enrollment information.
Where is the NCT05237934 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT05237934 clinical trial?
NCT05237934 is sponsored by National Cancer Institute (NCI). The principal investigator is Jaydira Del Rivero, M.D. at National Cancer Institute (NCI). The trial plans to enroll 300 participants.