Working… Menu

Studies on Tumors of the Thyroid

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. Identifier: NCT00001160
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : September 25, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:

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 or disease
Hurthle Cell Thyroid Cancer Tall Cell Variant Thyroid Cancer Follicular Thyroid Cancer Thyroid Cancer Papillary Thyroid Cancer

Detailed Description:

The purpose of this study is to evaluate methods for preoperative diagnosis and therapy of differentiated and medullary 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 administered according to standard clinical practice indications, and 68Gallium-DOTATATE (Octreotate)-administered per research protocol as indicated. 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 99999 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Studies on Thyroid Nodules and Thyroid Cancer
Actual Study Start Date : May 31, 1977

Thyroid Cancer
Patients with thyroid cancer

Primary Outcome Measures :
  1. Evaluation of thyroid cancer [ Time Frame: annually ]
    via blood draws, CT scans, physical examinations.

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.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Only those with thyroid tumors and/or thyroid cancer

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.


1. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma.

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 identifier (NCT number): NCT00001160

Layout table for location contacts
Contact: Craig S Cochran, R.N. (301) 402-1880
Contact: Joanna Klubo-Gwiezdzinska, M.D. (301) 496-5052

Layout table for location information
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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Layout table for investigator information
Principal Investigator: Joanna Klubo-Gwiezdzinska, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00001160     History of Changes
Other Study ID Numbers: 770096
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 18, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Thyroid Fine Needle Biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Cancer, Papillary
Adenocarcinoma, Follicular
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adenocarcinoma, Papillary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type