NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Gene Expression;
Epigenetic (methylation);
Tissues Histological Evaluations;
Establishment of Tumor Cell Lines;
Metabolite and Protein Expression;
Natural History

Recruitment Keyword(s)

Adrenal Cancer;
Endocrine Tumor;
Thyroid Cancer


Endocrine Tumors;
Thyroid Neoplasms;
Parathyroid Neoplasms;
Adrenal Neoplasm;

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Cancer Institute


- 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.

--Back to Top--



- 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, gastrointestinal

track 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.

Exclusion Criteria:


--Back to Top--


Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30.

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.

--Back to Top--


Principal Investigator

Referral Contact

For more information:

Naris Nilubol, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5952
(240) 760-6154

Kristine J. Villaruel
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D19
10 Center Drive
Bethesda, Maryland 20892
(240) 858-7033

Deborah E. Allen, R.N.
National Institutes of Health
Building 10
Room B2-5530
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6184

Clinical Trials Number:


--Back to Top--