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Weefselverkrijging en natuurlijke historiestudie van neuro-endocriene neoplasmata (NEN's) inclusief adrenocorticaal carcinoom (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 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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Jaydira Del Rivero, M.D.
- Telefoonnummer: (240) 858-3851
- E-mail: delriveroj@mail.nih.gov
Studie Contact Back-up
- Naam: Anna Liza F Rivero
- Telefoonnummer: (240) 858-7946
- E-mail: anna.rivero@nih.gov
Studie Locaties
-
-
Maryland
-
Bethesda, Maryland, Verenigde Staten, 20892
- Werving
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
- Telefoonnummer: 888-624-1937
-
Contact:
- Anna Rivero
- Telefoonnummer: (301) 451-7007
- E-mail: anna.rivero@nih.gov
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
primary clinical
Beschrijving
-
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
|---|
|
Cohort 1
Participants with confirmed/suspected NENs including ACC |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
natural history of neuroendocrine neoplasms including ACC
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jaydira Del Rivero, M.D., National Cancer Institute (NCI)
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 10000491
- 000491-C
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
All IPD recorded in the medical record will be shared with intramural investigators upon request.@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD-tijdsbestek voor delen
Clinical data available during the study and indefinitely.@@@@@@Genomic data will be available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD-toegangscriteria voor delen
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data will be made available via dbGaP through requests to the data custodians.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
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Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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