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Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01005654
Recruitment Status : Recruiting
First Posted : November 2, 2009
Last Update Posted : December 20, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


  • 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.

Condition or disease
Endocrine Tumors Thyroid Neoplasms Parathyroid Neoplasms Adrenal Neoplasm Neuroblastoma

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 1350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Study Start Date : September 23, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. To develop a genetic, epigenetic, metabolomic, and proteomic profile of endocrine neoplasm that will allow us to distinguish benign from malignant tumor for each of the endocrine histologies under study. [ Time Frame: ongoing ]

Secondary Outcome Measures :
  1. To utilize the tissue obtained from these endocrine neoplasms for studies of gene expression,epigenetic (methylation) changes, and metabolite and protein expression. [ Time Frame: ongoing ]
  2. To obtain, when accessible, normal endocrine and other adjacent tissue for comparison with the neoplastic tissue including the comparison of genomic profiling data to determine the best approach for normalizing expression data. [ Time Frame: ongoing ]
  3. 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. [ Time Frame: ongoing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Patients who have an endocrine neoplasm based on radiographic and biochemical testing, or histologically/cytologically proven lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, paragangliomas, neuroblastomas and pancreas or patients with a described pre or potentially malignant condition that requires surgery or biopsy as a part of the standard of care treatment and/or follow up.
  • Patients referred to the Endocrine Consult Service on other protocol for surgical evaluation of endocrine disorders based on radiographic and biochemical testing, or histologically/cytologically proven lesions of the thyroid, parathyroid, adrenal, extra-adrenal endocrine nests, 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.
  • Patients undergoing treatment for their neoplasm may be eligible.
  • Patients must be planning to undergo surgery or biopsy as part of their treatment plan. Note: Patients will not be enrolled exclusively for the procurement of tissue samples.
  • Age is greater than or equal to 4 years of age.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005654

Contact: Roxanne E Merkel (301) 402-4395 ncieobinquiry@mail.nih.gov
Contact: Electron Kebebew, M.D. (240) 760-6153 kebebewe@mail.nih.gov

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01005654     History of Changes
Other Study ID Numbers: 090242
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 11, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gene Expression
Epigenetic (methylation)
Tissues Histological Evaluations
Establishment of Tumor Cell Lines
Metabolite and Protein Expression
Adrenal Cancer
Endocrine Tumor
Thyroid Cancer

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Parathyroid Neoplasms
Adrenal Gland Neoplasms
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Parathyroid Diseases
Adrenal Gland Diseases