Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

2014-08-27 03:18:16 | BioPortfolio



- Endocrine neoplasms (tumors) are among the fastest growing tumors in incidence in the United States. Furthermore, it is often difficult to distinguish between benign or malignant tumors in cancers of the thyroid, parathyroid, adrenal gland, and pancreas. More research is needed to improve detection and treatment options for patients who develop these kinds of cancer.

- Researchers are interested in studying the molecular changes that are involved in endocrine cancer development and growth. To collect a sample of tumor specimens and healthy tissue for further study, researchers are specifically looking for samples from patients who are scheduled for surgery or biopsy on endocrine tumors.


- To collect samples of precancerous, cancerous, and healthy tissue from individuals who are scheduled for surgery or biopsy of endocrine system tumors.


- Individuals who have a tumor in or around their thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue, and are scheduled for surgery at the National Institutes of Health Clinical Center.


- Participants in this study will provide blood and urine samples prior to surgery.

- During the surgery or biopsy, pieces of the tumor or precancerous growth and pieces of normal tissue near to the tumor will be removed for ongoing and future research. The rest of the tumor or growth will be sent for analysis.

- After surgery, participants will receive routine care until discharge, and doctors will discuss possible treatment options. If there is an appropriate NIH protocol, participants may choose to be treated at the NIH.

- After discharge, participants will return to the clinic for a routine postoperative check about 6 weeks following the operation, and then may be followed yearly at the Clinical Center or by phone.



- Endocrine neoplasms are among the fastest growing tumors in incidence in the United States. Between 1995 and 2005, the incidence of thyroid carcinoma has increased 98 percent.

- Tumors of the thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among some of the most difficult tumors to clinically and histopathologically distinguish as benign or malignant.

- Moreover, endocrine neoplasm provide an extremely important model for studying the important molecular changes that lead to carcinogenesis because of their diverse clinical behavior, even when having the same TNM stage and histologic features.

- The Endocrine Surgery Section of the Surgery Branch, NCI has a focus on studying the molecular changes that are involved in Endocrine Cancer initiation and progression. In addition, this section has primary responsibility for providing endocrine surgery consultative services to the NIH. As such, our Section is uniquely positioned to acquire and perform important studies on endocrine tissue to help identify diagnostic and predictive markers, as well as, therapeutic targets that may have significant clinical ramifications. Some of the patients enrolled in this study may be on other protocols throughout the NIH, for which our Section is consulted in order to perform their operation.


Primary Objective:

- To develop a genetic and epigenetic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study. This objective will drive the statistical endpoints of the study.

Secondary Objectives:

- To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression and epigenetic (methylation) changes.

- To obtain, when accessible, adjacent normal endocrine tissue for comparison with the neoplastic tissue.

- To collect tissues from endocrine neoplasms arising in the thyroid, parathyroid, adrenal, pancreas, and extraadrenal neuroendocrine rests for future analysis and correlation with clinical outcome.


- Patients with radiographic evidence of, biochemical evidence of, or histologically/cytologically proven, endocrine neoplasms, including lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine rests, paragangliomas, neuroblastomas and pancreas.

- Patients must have an ECOG performance score of 0-2.

- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.


- A tissue acquisition trial in which tissues will be obtained at the time of surgical operation for the removal of neoplasms of the thyroid, parathyroid, adrenal, pancreas, and paragangliomas and or extraadrenal rests of neuroendocrine tissue.

- Tissue and blood will be processed at the time of collection, stored and then transferred to Dr. Kebebew's laboratory for further processing.

- No investigational therapy will be given.

- It is anticipated that 1350 patients will be enrolled over a period of 16 years.

Study Design

Time Perspective: Prospective


Neuroendocrine Neoplasms


National Institutes of Health Clinical Center, 9000 Rockville Pike
United States




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:16-0400

Clinical Trials [283 Associated Clinical Trials listed on BioPortfolio]

A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms

The aim of this study is to investigate the clinical value of [18F]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide(18F-AlF-NOTA-octreotide ) positron emission...

A Phase II Study of Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin

Well-differentiated gastroenteropancreatic and lung neuroendocrine tumors are generally malignancies with a prolonged natural history. However, clinical behavior is heterogeneous and when ...

Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms

68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of ...

TEMCAP in Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors

GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors. Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This classi...

Imaging of Neuroendocrine Tumors With PET and Fluoro-18-DOPA (F-DOPA)

Imaging of neuroendocrine (NETs), such as carcinoids and pheochromocytomas (PHEOs), is suboptimal, limiting curative treatment. The investigators wanted to explore the use of PET and F-DOP...

PubMed Articles [836 Associated PubMed Articles listed on BioPortfolio]

Unmet Needs in Functional and Nonfunctional pancreatic neuroendocrine neoplasms(PanNENs).

Recently, European Neuroendocrine Tumor Society (ENETS )held working sessions composed of members of the advisory board and other Neuroendocrine neoplasms (NEN) experts to attempt to identify unmet ne...

Downregulated Pancreatic Beta Cell Genes Indicate Poor Prognosis in Patients With Pancreatic Neuroendocrine Neoplasms.

To predict metachronous liver metastasis after pancreatectomy for pancreatic neuroendocrine neoplasms (Pan-NENs).

Autotaxin upregulated by STAT3 activation contributes to invasion in pancreatic neuroendocrine neoplasms.

Although the upregulation of autotaxin (ATX) is associated with many solid tumours, its role in pancreatic neuroendocrine neoplasms (pNEN) has not been well elucidated.

Prognostic Evaluations Tailored to Specific Gastric Neuroendocrine Neoplasms: Analysis Of 200 Cases with Extended Follow-Up.

Gastric neuroendocrine neoplasms (NENs) are very heterogeneous, ranging from mostly indolent, atrophic gastritis-associated, type I neuroendocrine tumors (NETs), through highly malignant, poorly diffe...

The prognosis and management of neuroendocrine neoplasms-related metastatic bone disease: lessons from clinical practice.

To study the evolution and optimal management of metastatic bone disease (mBD) in patients with neuroendocrine neoplasms (NENs).

Medical and Biotech [MESH] Definitions

Tumors whose cells possess secretory granules and originate from the neuroectoderm, i.e., the cells of the ectoblast or epiblast that program the neuroendocrine system. Common properties across most neuroendocrine tumors include ectopic hormone production (often via APUD CELLS), the presence of tumor-associated antigens, and isozyme composition.

A 38-kDa integral membrane glycoprotein of the presynaptic vesicles in neuron and neuroendocrine cells. It is expressed by a variety of normal and neoplastic neuroendocrine cells and is therefore used as an immunocytochemical marker for neuroendocrine differentiation in various tumors. In ALZHEIMER DISEASE and other dementing disorders, there is an important synapse loss due in part to a decrease of synaptophysin in the presynaptic vesicles.

An acidic protein found in the NEUROENDOCRINE SYSTEM that functions as a molecular chaperone for PROPROTEIN CONVERTASE 2.

A collective term for precoordinated organ/neoplasm headings locating neoplasms by organ, as BRAIN NEOPLASMS; DUODENAL NEOPLASMS; LIVER NEOPLASMS; etc.

A group of carcinomas which share a characteristic morphology, often being composed of clusters and trabecular sheets of round "blue cells", granular chromatin, and an attenuated rim of poorly demarcated cytoplasm. Neuroendocrine tumors include carcinoids, small ("oat") cell carcinomas, medullary carcinoma of the thyroid, Merkel cell tumor, cutaneous neuroendocrine carcinoma, pancreatic islet cell tumors, and pheochromocytoma. Neurosecretory granules are found within the tumor cells. (Segen, Dictionary of Modern Medicine, 1992)

More From BioPortfolio on "Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms"

Quick Search


Relevant Topics

Endocrine Disorders
Endocrine disorders are grouped into two categories: hormone imbalance - when a gland produces too much or too little of an endocrine hormone development of lesions (such as nodules or tumors) in the endocrine system, which may or may not affect...

Thyroid Disorders
The thyroid is a butterfly-shaped gland in the neck, just above thecollarbone and is an endocrine gland that make hormones. These Thyroid hormones control the rate of many activities in the body, including how fast the body burns calories and how fast th...

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Searches Linking to this Trial