Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 77-DK-0096 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thyroid cancer | Patients with thyroid cancer |
| |
| thyroid nodules | Patients with thyroid nodules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68-Gallium Dotatate | Drug | For evaluation risk/benefit evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of thyroid cancer | Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable). | As clinically indicated |
| Evaluation of thyroid disorders | blood draws, CT and other scans, physical exam. | As clinically indicated |
Not provided
Not provided
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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.
Not provided
Not provided
Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Padmasree Veeraraghavan, R.N. | Contact | (301) 451-7710 | padmasree.veeraraghavan@nih.gov | |
| Joanna Klubo-Gwiezdzinska, M.D. | Contact | (301) 496-5052 | joanna.klubo-gwiezdzinska@nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Joanna Klubo-Gwiezdzinska, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30032182 | Background | 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. | |
| 31620364 | Background | 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C536913 | Thyroid cancer, Hurthle cell |
| D018263 | Adenocarcinoma, Follicular |
| D013964 | Thyroid Neoplasms |
| D000077273 | Thyroid Cancer, Papillary |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D000231 | Adenocarcinoma, Papillary |