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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00001160
Other study ID # 770096
Secondary ID 77-DK-0096
Status Recruiting
Phase
First received
Last updated
Start date June 1, 1977

Study information

Verified date May 22, 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
Health authority
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
Est. completion date
Est. primary completion date
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.

Study Design


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
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