Studies on Tumors of the Thyroid

NCT ID: NCT00001160

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1977-06-01

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.

Conditions

Hurthle Cell Thyroid Cancer; Tall Cell Variant Thyroid Cancer; Follicular Thyroid Cancer; Thyroid Cancer; Papillary Thyroid Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

thyroid cancer

Patients with thyroid cancer

68-Gallium Dotatate

Intervention Type: DRUG

For evaluation risk/benefit evaluation

thyroid nodules

Patients with thyroid nodules

68-Gallium Dotatate

Intervention Type: DRUG

For evaluation risk/benefit evaluation

Interventions

68-Gallium Dotatate

For evaluation risk/benefit evaluation

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 98 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanna Klubo-Gwiezdzinska, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Padmasree Veeraraghavan, R.N.

Role: CONTACT

padmasree.veeraraghavan@nih.gov

(301) 451-7710

Joanna Klubo-Gwiezdzinska, M.D.

Role: CONTACT

joanna.klubo-gwiezdzinska@nih.gov

(301) 496-5052

Facility Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

ccopr@nih.gov

800-411-1222 ext. TTY dial 711

References

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.

Reference Type: BACKGROUND

PMID: 30032182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31620364 (View on PubMed)

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1977-DK-0096.html

NIH Clinical Center Detailed Web Page

Other Identifiers

77-DK-0096

Identifier Type: -

Identifier Source: secondary_id

770096

Identifier Type: -

Identifier Source: org_study_id