Protocol Details

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	09-C-0242
Sponsoring Institute	National Cancer Institute (NCI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 7 Max Age: 100
Referral Letter Required	No
Population Exclusion(s)	None
Special Instructions	Currently Not Provided
Keywords	Gene Expression; Thyroid Cancer; Adrenal Cancer; Neuroendocrine Tumors; Parathyroid Disease
Recruitment Keyword(s)	Adrenal Cancer; Endocrine Tumor; Thyroid Cancer
Condition(s)	Neuroendocrine Neoplasms; Thyroid Neoplasms; Parathyroid Neoplasms; Adrenal Neoplasm; Neuroblastoma
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Cancer Institute

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.

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Eligibility

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.

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Citations:

Lee PK, Jarosek SL, Virnig BA, Evasovich M, Tuttle TM. Trends in the incidence and treatment of parathyroid cancer in the United States. Cancer. 2007 May 1;109(9):1736-41.

Howlett DC, Speirs A. The thyroid incidentaloma--ignore or investigate? J Ultrasound Med. 2007 Oct;26(10):1367-71.

Kwak JY, Kim EK, Moon HJ, Kim MJ, Ahn SS, Son EJ, Sohn YM. Parathyroid incidentalomas detected on routine ultrasound-directed fine-needle aspiration biopsy in patients referred for thyroid nodules and the role of parathyroid hormone analysis in the samples. Thyroid. 2009 Jul;19(7):743-8.

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Contacts:

Principal Investigator	Referral Contact
Electron Kebebew, M.D. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 3-3940 10 Center Drive Bethesda, Maryland 20892 (301) 496-4164 kebebewe@mail.nih.gov	Krisana Gesuwan, C.R.N.P. National Cancer Institute (NCI) National Institutes of Health Building 10 Room 4-3740 10 Center Drive Bethesda, Maryland 20892 (301) 402-4395 gesuwank2@mail.nih.gov

Clinical Trials Number:

NCT01005654

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