Hurthle Cell Thyroid CancerNCT00001160
Studies on Tumors of the Thyroid
An observational study of Hurthle Cell Thyroid Cancer and Tall Cell Variant Thyroid Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 98 years
- Conditions the study is for
- Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer, Follicular Thyroid Cancer
- What is being tested?
- 68-Gallium Dotatate
- How many people
- 2,500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 1977to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 98 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, adults or children >= 6 months+.
- Patients with known or suspected thyroid nodules and/or thyroid cancer.
- At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Studies on Thyroid Nodules and Thyroid Cancer
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.
Read the 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.
- Conditions
- Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer, Follicular Thyroid Cancer, Thyroid Cancer, Papillary Thyroid Cancer
- Being tested
- 68-Gallium Dotatate
- Keywords
- Thyroid Fine Needle Biopsy, Radioiodine, Dosimetry, Natural History
- Medical subject headings
- Thyroid cancer, Hurthle cell, Adenocarcinoma, Follicular, Thyroid Neoplasms, Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-Gallium DotatateDrug
For evaluation risk/benefit evaluation
| Study group | Role | What they receive |
|---|---|---|
| thyroid cancer | Patients with thyroid cancer Receives: Drug: 68-Gallium Dotatate | |
| thyroid nodules | Patients with thyroid nodules Receives: Drug: 68-Gallium Dotatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of thyroid cancer
Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).
Measured: As clinically indicated
Evaluation of thyroid disorders
blood draws, CT and other scans, physical exam.
Measured: As clinically indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start1 Jun 1977
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hurthle Cell Thyroid CancerStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joanna Klubo-Gwiezdzinska, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001160
- Sponsor's protocol ID
- 770096
- Other IDs
- 77-DK-0096
- Status last verified
- 18 Aug 2026
- First submitted
- 3 Nov 1999
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Publications
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.
PubMed 30032182Thakur 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.
PubMed 31620364