- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05237934
Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC)
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sarah Kelley
- Phone Number: (240) 753-1971
- Email: sarah.kelley@nih.gov
Study Contact Backup
- Name: Jaydira Del Rivero, M.D.
- Phone Number: (240) 858-3851
- Email: delriveroj@mail.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
- Phone Number: 888-624-1937
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Cohort 1
Participants with confirmed/suspected NENs including ACC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
natural history of neuroendocrine neoplasms including ACC
Time Frame: ongoing
|
To comprehensively and longitudinally evaluate the natural history of participants with NENs and allow sample acquisition for use in the study of NENs
|
ongoing
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jaydira Del Rivero, M.D., National Cancer Institute (NCI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Adrenal Gland Diseases
- Adrenal Cortex Neoplasms
- Adrenal Gland Neoplasms
- Adrenal Cortex Diseases
- Neoplasms
- Carcinoma
- Carcinoma, Neuroendocrine
- Neuroendocrine Tumors
- Adrenocortical Carcinoma
Other Study ID Numbers
- 10000491
- 000491-C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroendocrine Tumors
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Gastroenteropancreatic Neuroendocrine TumorChina
-
Jiangsu HengRui Medicine Co., Ltd.Not yet recruitingAdvanced Gastroenteropancreatic Neuroendocrine Tumor
-
National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical... and other collaboratorsRecruitingNeuroendocrine Tumors,GastroenteropancreaticTaiwan
-
Grupo Espanol de Tumores NeuroendocrinosActive, not recruitingNeuroendocrine Tumors | Neuroendocrine Neoplasm | Gastroenteropancreatic Neuroendocrine TumorSpain
-
Amr Mohamed MDNovatek PharmaceuticalsRecruitingNeuroendocrine Carcinoma | Gastroenteropancreatic Neuroendocrine Tumor | Gastroenteropancreatic Neuroendocrine Neoplasm | Mixed Neuroendocrine-Non Neuroendocrine NeoplasmUnited States
-
Francesco De CobelliCompleted
-
Australasian Gastro-Intestinal Trials GroupCompletedMidgut Neuroendocrine Tumours | Pancreatic Neuroendocrine TumoursAustralia
-
TaiRx, Inc.Active, not recruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Tumor | Lung Neuroendocrine NeoplasmTaiwan
-
Memorial Sloan Kettering Cancer CenterRecruitingNeuroendocrine Tumors | Liver-Dominant Metastatic Pancreatic Neuroendocrine TumorsUnited States
-
University Hospital, Basel, SwitzerlandSwiss National Science Foundation; Paul Scherrer Institute (PSI)RecruitingNeuroendocrine Neoplasia's (NENs) | Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)Switzerland