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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000491-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Adults who are or may become unable to consent;
Children

Keywords

Clinical Outcome;
Advice in the Management of Cancer;
Patterns of Disease Progression;
Response or Lack of Response to Therapeutic Interventions;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Neuroendocrine Tumors;
Carcinoma, Neuroendocrine

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jaydira Del Rivero, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13C434
10 CENTER DR
BETHESDA MD 20892
(240) 858-3851
delriveroj@mail.nih.gov

Sarah Kelley
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44
10 Center Drive
Bethesda, Maryland 20892
(240) 753-1971
sarah.kelley@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT05237934

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