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Home > "S" Clinical Trials Conditions > Studies on Tumors of the Thyroid  Studies on Tumors of the Thyroid
Studies on Tumors of the Thyroid
For Condition: Neoplasm Metastasis,Thyroid Neoplasm,Thyroid Nodule
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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.
Details: The purpose of this study is to evaluate methods for preoperative diagnosis of thyroid nodules and for the diagnosis and therapy of metastatic thyroid cancer. Furthermore, the project has as an aim to study the molecular events accompanying the natural history of thyroid cancer and the response of various molecular markers to standard therapeutic intervention. The preoperative diagnostic methods include aspiration cytology, ultrasonography, thyroid scanning with radioactive iodine (radioiodine or 131 I) and /or other radionuclides, and suppression therapy with L-thyroxine. Specific issues concerning thyroid cancer which are addressed in this study include: The optimization of methods for follow-up of patients using radiopharmaceutical tracers for diagnostic tests in thyroid cancer (administered according to standard clinical practice indications and published guidelines): More specifically, we will address the questions of the optimal amount of 131I tracer (currently clinically acceptable range: 0.5-5 mCi) that should be used for diagnostic studies, the timing of the administration of 131 I for diagnostic purposes in relationship to the subsequent administration of a therapeutic dose, and the exact role of diagnostic scanning using radiopharmaceuticals other than 131 I, such as 123 I, 201 T1 chloride, 99m Tc-Sestamibi, and 111 In-pentetreotide, in highly selected cases of thyroid cancer (as an alternative to 131 I imaging for post-thyroidectomy scans). The use of serum thyroglobulin (Tg) measurement in diagnosing tumor recurrence. The refinement and improvement of the risk/benefit ratio of already established methods of administering 131 I therapy (which remains the cardinal therapeutic modality in thyroid cancer): More specifically, we will address the questions of the optimal regimen of administration of 131 I therapy to patients whose serumTg levels are abnormal, but whose diagnostic 131 I scans are negative, as well as the long-term 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 150 mCi) 131I therapy is clinically indicated. The use of RNA detection and quantification methods (i.e., polymerase chain reaction [PCR]) specific for various mRNAs (including Tg mRNA) in thyrocytes existing in peripheral blood, as well as measurement of the expression of a number of thyroid-specific differentiation markers (Na+/I- symporter [NIS], thyroglobulin [Tg], thyroid peroxidase [TPO], iodothyronine 5'-deiodinase type I [5'-DI], and the thyrotropin (TSH) receptor [TSHR]). Mutational analysis of genes involved in cancer growth, apoptosis, and mitotic cycle regulation (TSHR, ras, p53, Fas/Fas ligand, and ret/PTC) in genetic material isolated from specimens obtained from the primary thyroid tumor, as well as metastatic deposits (the latter specimens will be obtained only when biopsy of metastases is clinically indicated). Finally, The establishment of immortalized cell lines that derive from thyroid carcinomas for future in vitro studies. The study subjects include patients with thyroid nodules requiring surgical biopsy, patients with an established diagnosis of thyroid cancer requiring radioiodine testing, patients requiring radioiodine therapy for inoperable metastatic disease, as well as patients with clinically aggressive thyroid carcinomas (which are usually established high-grade metastatic neoplasms that have lost their iodine trapping ability). In this study, 131 I will be used for therapy only when clinically indicated, and , in fact, there is no "research" indication for the use of either 131 I or other radionuclides in the realms of diagnosis and therapy. Patients who are allowed to become hypothyroid for medically indicated testing of 131 I uptake may be asked to participate in studies related to the hypothyroid state. If more than trivial measurements are performed, these patients are entered into separate protocols.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients of any age at risk for thyroid carcinoma will be selected. The section of our study relevant to the detection and analysis of nRNA transcripts for specific genes in circulating throcytes in peripheral blood of patients with previously treated thyroid cancer will also include patients of all ages. EXCLUSION CRITERIA: All patients under age 18 (minors) will be excluded from the part of our study necessitating collection of specimens by fine needle aspiration of primary thyroid and metastatic lesions that are specifically and solely obtained for research purposes.
Total Enrollment: 999
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 770096; 77-DK-0096
Study Start Date: May 31, 1977
Record last reviewed: May 23, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001160
Other Thyroid Nodule Studies:
1. Studies on Tumors of the Thyroid
Related Studies:
Other Thyroid Nodule Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Studies on Tumors of the Thyroid
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