Studies on Tumors of the Thyroid

Thyroid Cancer Clinical Trial

Official title:

Studies on Thyroid Nodules and Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001160
• Other study ID #: 770096
• Secondary ID: 77-DK-0096
• Status: Recruiting
• Start date: June 1, 1977

Study information

• Verified date: May 6, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Padmasree Veeraraghavan, N.P.
• Phone: (301) 451-7710
• Email: padmasree.veeraraghavan[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of thyroid cancer using established best standard of care and new techniques and approaches as they are developed. Study subjects will include adults and children with thyroid nodules requiring diagnostic imaging and fine needle aspiration biopsy, surgery, radioiodine scanning or therapy, appropriate follow up, consisting of tumor markers monitoring and anatomical and functional imaging. 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 radioiodine therapy, including the impact of pre-treatment dosimetric calculations, individualizing treatment with radioiodine. Under this protocol, samples of benign nodules and cancer tissue specimens for research studies will be collected. Data and samples collected during routine clinical care will be used to address research questions utilizing a number of approaches including microscopy, immunohistochemistry, proteomics and molecular analysis. All research studies will relate to the diagnosis, natural history and therapy of thyroid tumors, regulation of thyroid function, and the effects of thyroid function on the body. Blood and urine specimens will be collected for research studies in both the hypothyroid and euthyroid state.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 98 Years

Eligibility

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the

following criteria:

1. Male or female, adults or children >= 6 months+.

2. Patients with known or suspected thyroid nodules and/or thyroid cancer.

3. At risk family members of patients who have a genetic susceptibility to developing thyroid cancer. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation

in this study:

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

Related Conditions & MeSH terms

• Follicular Thyroid Cancer
• Hurthle Cell Thyroid Cancer
• Papillary Thyroid Cancer
• Tall Cell Variant Thyroid Cancer
• Thyroid Cancer
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• 68-Gallium Dotatate
For evaluation risk/benefit evaluation

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Klubo-Gwiezdzinska J, Wartofsky L. The Role of Molecular Diagnostics in the Management of Indeterminate Thyroid Nodules. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3507-3510. doi: 10.1210/jc.2018-01081. — View Citation

Thakur S, Tobey A, Daley B, Auh S, Walter M, Patel D, Nilubol N, Kebebew E, Patel A, Jensen K, Vasko V, Klubo-Gwiezdzinska J. Limited Utility of Circulating Cell-Free DNA Integrity as a Diagnostic Tool for Differentiating Between Malignant and Benign Thyroid Nodules With Indeterminate Cytology (Bethesda Category III). Front Oncol. 2019 Sep 18;9:905. doi: 10.3389/fonc.2019.00905. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of thyroid cancer	Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).	As clinically indicated
Primary	Evaluation of thyroid disorders	blood draws, CT and other scans, physical exam.	As clinically indicated

External Links

•   NIH Clinical Center Detailed Web Page