Bethesda, Maryland 20892


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.


Study summary:

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, (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 FNAB, benign nodules and cancer tissue specimens, blood samples for research studies will be collected to assess new immunohistochemical and molecular markers, and other techniques to characterize tumors for correlation with diagnosis, response to therapy and prognosis. Blood and urine 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.


Criteria:

- INCLUSION CRITERIA: Adults and children with known or suspected thyroid neoplasm will be considered for participation. 1. Patients with thyroid nodules requiring evaluation and possible biopsy 2. Patients with recent diagnosis of thyroid cancer requiring consultation and counseling about therapeutic options 3. Patients with established thyroid cancer requiring specialized studies such as (131)I dosimetry 4. Enrollment of high risk, non-iodine avid, inoperable thyroid cancer for standard treatment of screening for eligibility for other specific thyroid cancer protocols. EXCLUSION CRITERIA: 1. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;


NCT ID:

NCT00001160


Primary Contact:

Principal Investigator
Joanna Klubo-Gwiezdzinska, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Craig S Cochran, R.N.
Phone: (301) 402-1880
Email: craigc@bdg10.niddk.nih.gov


Backup Contact:

Email: joanna.klubo-gwiezdzinska@nih.gov
Joanna Klubo-Gwiezdzinska, M.D.
Phone: (301) 496-5052


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 26, 2017

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