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RecruitingNCT00001160Updated Nov 9, 2026

Studies on Tumors of the Thyroid

An observational study in Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer and Follicular Thyroid Cancer, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 6 Months to 98 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

From the registry’s dates

  • Started Jun 1977; still recruiting 49 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,500
Ages
6 Months to 98 Years
Sex
All
01

Study 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....

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.

02

Conditions studied

  • 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
03

In context

Adenocarcinoma, Follicular

66 studies on the registry are indexed under Adenocarcinoma, Follicular; 8 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 75 across 10 observational studies indexed under Adenocarcinoma, Follicular.

Browse Adenocarcinoma, Follicular studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 98 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,500 participants (estimated)

Groups and cohorts

  • thyroid cancer

    Patients with thyroid cancer

    Drug: 68-Gallium Dotatate

  • thyroid nodules

    Patients with thyroid nodules

    Drug: 68-Gallium Dotatate

Interventions

  • Drug68-Gallium Dotatate

    For evaluation risk/benefit evaluation

06

What researchers measure

Primary outcomes

  1. Evaluation of thyroid cancer

    Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).

    Time frame: As clinically indicated

  2. Evaluation of thyroid disorders

    blood draws, CT and other scans, physical exam.

    Time frame: As clinically indicated

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

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 30032182 ↗
  • 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. PubMed 31620364 ↗

Individual participant data

Plan to share: Undecided — Subject level data will be shared upon request after appropriate collaboration agreements are in place.

09

Timeline

7 registry updates since Sep 25, 2026

Started Jun 1977 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 1999
First posted
Nov 4, 1999
StartActual
Jun 1, 1977
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: description
7 updates, last Nov 9, 2026
Show all 7 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Oct 29, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 16, 2026
    Minor edits only
    + 1 other change: description
  5. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  6. Oct 8, 2026
    Minor edits only
    + 1 other change: description
  7. Oct 2, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00001160
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Jun 1, 1977
Last update
Nov 9, 2026

Study contacts

Padmasree Veeraraghavan, R.N.
Contact
padmasree.veeraraghavan@nih.gov
(301) 451-7710
Joanna Klubo-Gwiezdzinska, M.D.
Contact
joanna.klubo-gwiezdzinska@nih.gov
(301) 496-5052
Joanna Klubo-Gwiezdzinska, M.D.
principal investigator · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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