Clinical trial NCT00001160: Studies on Tumors of the Thyroid
Official title: Studies on Thyroid Nodules and Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hurthle Cell Thyroid Cancer
Tall Cell Variant Thyroid Cancer
Follicular Thyroid Cancer
Thyroid Cancer
Papillary Thyroid Cancer
Keywords: Thyroid Fine Needle Biopsy
Radioiodine
Dosimetry
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 2500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 98
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.

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.

Detailed 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Evaluation of thyroid cancer
timeFrame: As clinically indicated
measure: Evaluation of thyroid disorders
timeFrame: As clinically indicated
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Joanna Klubo-Gwiezdzinska, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.