Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
This study is currently recruiting participants.
Verified April 2013 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: May 1, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
neuroblastoma
MedlinePlus related topics:
Adrenal Gland Cancer
Cancer
Neuroblastoma
Parathyroid Disorders
Thyroid Cancer
Thyroid Diseases
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005654
Contacts
| Contact: Erinn Hopkins | (301) 496-6457 | hopkinsem@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: Krisana Gesuwan, M.S.N. 301-402-4395 gesuwank2@mail.nih.gov | |
| Contact: Jean Ward (301) 827-4988 jean.ward@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: | May 1, 2013 |
| 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 Neoplasms Thyroid Neoplasms Endocrine Gland Neoplasms Neuroblastoma Parathyroid Neoplasms Thyroid Diseases Neuroendocrine Tumors Neoplasms by Site Adrenal Gland Diseases Endocrine System Diseases |
Head and Neck 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 Parathyroid Diseases |
ClinicalTrials.gov processed this record on May 16, 2013