Studies on Tumors of the Thyroid - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001160

Purpose

Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer.

The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.

Condition
Neoplasm Metastasis Thyroid Neoplasm Thyroid Nodule

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Thyroid

U.S. FDA Resources

Study Type:	Observational
Official Title:	Studies on Thyroid Nodules and Thyroid Cancer

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

Study Start Date:

May 1977

Detailed Description:

The purpose of this study is to evaluate methods for preoperative diagnosis and therapy of thyroid cancer and to screen patients for participation in other protocols. Study subjects will include adults and children with thyroid nodules or cancer requiring diagnostic fine needle aspiration biopsy, surgery, radioiodine scanning or therapy for persistent or recurrent disease.

In this natural history protocol, the use of methods for follow-up of patients using radiopharmaceutical tracers such as (131)I, (123)I, (201)T1 chloride, (99)mTc-Sestamibi, (111)Inpentetreotide and 18-FDG PET will be evaluated. All radionuclides will be administered according to standard clinical practice indications and published guidelines. The limitations and significance of serum thyroglobulin (Tg) measurement for diagnosing tumor recurrence will be assessed. The study will permit a continued evaluation of the risk/benefit ratio of already established methods of administering (131)I therapy including the impact of pre-treatment dosimetric calculations and administration of lithium (a well established, yet not widely used, adjuvant to (131)I treatment), especially in selected cases of thyroid cancer in which high-dose (greater than 150mCi) (131)I therapy is clinically indicated.

Under this protocol, samples of benign nodules and cancer tissue specimens for research studies will be collected to assess new immunohistochemical markers, and other techniques to characterize tumors for correlation with response to therapy and prognosis. Blood specimens will be collected for future clinical and research studies in both the hypothyroid and euthyroid state. Coded clinical data will be entered in the National Thyroid Cancer Registry in selected patients.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Adults and children with known or suspected thyroid neoplasm will be considered for participation. Enrollment will be capped accordingly:

Patients with thyroid nodules requiring evaluation and possible biopsy (no more than 30 per year);
Patients with recent diagnosis of thyroid cancer requiring consultation and counseling about therapeutic options (no more than 10 per year);
Patients with established thyroid cancer requiring specialized studies such as (131)I dosimetry (no more than 5 per year);
Enrollment of high risk, non-iodine avid, inoperable thyroid cancer only for purposes of screening for eligibility for other specific thyroid cancer protocols.

EXCLUSION CRITERIA:

Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;
Patients unable or unwilling to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001160

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

Lakshmanan M, Schaffer A, Robbins J, Reynolds J, Norton J. A simplified low iodine diet in I-131 scanning and therapy of thyroid cancer. Clin Nucl Med. 1988 Dec;13(12):866-8.

Schneider AB, Line BR, Goldman JM, Robbins J. Sequential serum thyroglobulin determinations, 131I scans, and 131I uptakes after triiodothyronine withdrawal in patients with thyroid cancer. J Clin Endocrinol Metab. 1981 Dec;53(6):1199-206. No abstract available.

Robbins J, Merino MJ, Boice JD Jr, Ron E, Ain KB, Alexander HR, Norton JA, Reynolds J. Thyroid cancer: a lethal endocrine neoplasm. Ann Intern Med. 1991 Jul 15;115(2):133-47. Review.

Study ID Numbers:	770096, 77-DK-0096
Study First Received:	November 3, 1999
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00001160
Health Authority:	United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):

Thyroid
Nodules
Cancer
Clinically Aggressive
Radioiodine

Dosimetry
High Dose Therapy
FDG-PET Scanning
Fine Needle Aspiration Biopsy

Study placed in the following topic categories:

Thyroid Nodule
Thyroid Neoplasms
Head and Neck Neoplasms
Neoplasm Metastasis
Endocrine System Diseases

Endocrinopathy
Aggression
Thyroid Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009