Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01005654
First received: October 30, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

Background:

  • 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.

Objectives:

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

Eligibility:

- 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.

Design:

  • 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
Neuroendocrine Neoplasms
Thyroid Neoplasms
Parathyroid Neoplasms
Adrenal Neoplasm
Neuroblastoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1350
Study Start Date: September 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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 rests, 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 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005654

Contacts
Contact: Roxanne E Merkel (301) 402-4395 merkelre@mail.nih.gov
Contact: Electron Kebebew, M.D. (301) 496-5049 kebebewe@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kaitlyn Chambers    301-402-4395    kaitlyn.chambers@nih.gov   
Contact: Roxanne Merkel    (301) 402-4395    merkelre@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01005654     History of Changes
Other Study ID Numbers: 090242, 09-C-0242
Study First Received: October 30, 2009
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Gene Expression
Thyroid Cancer
Adrenal Cancer
Neuroendocrine Tumors
Parathyroid Disease
Endocrine Tumor

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

ClinicalTrials.gov processed this record on October 23, 2014