Studies on Tumors of the Thyroid
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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 |
|---|
|
Hurthle Cell Thyroid Cancer Tall Cell Variant Thyroid Cancer Follicular Thyroid Cancer Thyroid Cancer Papillary Thyroid Cancer |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | Studies on Thyroid Nodules and Thyroid Cancer |
- Evaluation of thyroid cancer [ Time Frame: ongoing ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 99999999 |
| Study Start Date: | May 1977 |
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 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00001160
| Contact: Craig S Cochran, R.N. | (301) 402-1880 | craigc@bdg10.niddk.nih.gov | |
| Contact: Monica C Skarulis, M.D. | (301) 496-6087 | monicas@intra.niddk.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Monica C Skarulis, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ) |
| ClinicalTrials.gov Identifier: | NCT00001160 History of Changes |
| Other Study ID Numbers: | 770096, 77-DK-0096 |
| Study First Received: | November 3, 1999 |
| Last Updated: | January 16, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Thyroid Fine Needle Biopsy Radioiodine Dosimetry |
Additional relevant MeSH terms:
|
Thyroid Diseases Thyroid Neoplasms Adenocarcinoma, Follicular Adenocarcinoma Carcinoma Endocrine Gland Neoplasms |
Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on February 27, 2015