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Studies on Tumors of the Thyroid

This study is currently recruiting participants.

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Verified August 28, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Sponsor:

ClinicalTrials.gov Identifier:

NCT00001160

First Posted: November 4, 1999

Last Update Posted: September 15, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

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:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Studies on Thyroid Nodules and Thyroid Cancer

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid

Genetic and Rare Diseases Information Center resources: Papillary Thyroid Carcinoma Adult T-cell Leukemia/lymphoma Thyroid Cancer, Follicular Hurthle Cell Thyroid Cancer

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):

Primary Outcome Measures:

Evaluation of thyroid cancer [ Time Frame: ongoing ]


Estimated Enrollment:	99999
Study Start Date:	May 31, 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, (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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Adults and children with known or suspected thyroid neoplasm will be considered for participation.

Patients with thyroid nodules requiring evaluation and possible biopsy
Patients with recent diagnosis of thyroid cancer requiring consultation and counseling about therapeutic options
Patients with established thyroid cancer requiring specialized studies such as (131)I dosimetry
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;

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001160

Contacts


Contact: Craig S Cochran, R.N.	(301) 402-1880	craigc@bdg10.niddk.nih.gov
Contact: Joanna Klubo-Gwiezdzinska, M.D.	(301) 496-5052	joanna.klubo-gwiezdzinska@nih.gov

Locations


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

Sponsors and Collaborators

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

Investigators


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

More Information

Additional 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.

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.


Responsible Party:	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
First Submitted:	November 3, 1999
First Posted:	November 4, 1999
Last Update Posted:	September 15, 2017
Last Verified:	August 28, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):


Thyroid Fine Needle Biopsy Radioiodine Dosimetry

Additional relevant MeSH terms:


Thyroid Diseases Thyroid Neoplasms Carcinoma Adenocarcinoma, Follicular Endocrine System Diseases Endocrine Gland Neoplasms	Neoplasms by Site Neoplasms Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma

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