Recruiting

Understanding and Managing Thyroid Function Disorders: Clinical Data and Biospecimen Repository

Study Aim

This observational study aims to evaluate thyroid disorders by conducting routine examinations, standard endocrine tests, and various imaging studies, as clinically indicated, to understand and manage thyroid function disorders better.

What is being collected

Data Collection

Collected from past medical records and data - Retrospective

Who is being recruted

Endocrine System Diseases+1

+ Thyroid Diseases

+ Hyperthyroidism

From 6 Months to 98 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.

Observational

Study Start: February 1977

See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study ContactPadmasree Veeraraghavan, R.N.More contacts

Last updated: October 5, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1977

Actual date on which the first participant was enrolled.

Study Description: Participants with known or suspected thyroid function abnormalities (hyperthyroidism, hypothyroidism, extreme iodine deficiency, and inherited forms of hypothyroidism resulting from abnormalities in the expression of genes coding for the TSH- beta subunit, Pax-8, TTF-2, Pit-I, Tg, PDS, and NIS) and/or with thyroid function tests abnormalities. Participants undergo routine examinations and other standard diagnostic procedures, as clinically indicated. Blood, urine, and leftover thyroid or pituitary tissue specimens will be collected for research. Objectives: 1. To understand the pathophysiology and various causes of thyroid function abnormalities (e.g., hyperthyroidism, hypothyroidism). 2. To longitudinally follow the effects of standard therapies for participants with abnormal thyroid functions. 3. To create a repository of clinical data and samples for future research of thyroid disorders. Endpoints: None

NCT00001159

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study ContactPadmasree Veeraraghavan, R.N.More contacts

Last updated: October 5, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

2500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 Months to 98 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesThyroid DiseasesHyperthyroidismHypothyroidism

Criteria

7 inclusion criteria required to participate

1. Stated willingness to comply with all study procedures and availability for the duration of the study

2. Male or female, aged 6 months+

Hyperthyroid states include but are not restricted to: 1. Graves' disease (GD) thought to result from thyroid-stimulating immunoglobulins (TSIg's), a subclass of which also stimulate eye muscle and fatty tissue producing exophthalmos (Graves' ophthalmopathy), as well as the skin in the pretibial area causing pretibial myxedema (Graves' dermopathy); 2. Subacute thyroiditis (SAT), a painful inflammation thought to result from viral infection with Coxsackie, as well as other viruses; 3. Silent thyroiditis, a painless inflammation thought to result from autoimmune attack of thyrocytes by antimicrosomal antibodies directed against thyroid peroxidase (TPO), as well as antithyroglobulin(anti-Tg) antibodies; 4. Single or multiple hyperfunctioning thyroid nodules of unknown etiology, probably resulting from the activation of certain thyroid oncogenes and/or growth factors, such as the thyrotropin (TSH) receptor (TSHR) and the a-subunit of the G protein (Ga); 5. Iodide-induced hyperthyroidism of unknown etiology; 6. Surreptitious administration of thyroid hormone (TH), usually present in patients with underlying psychiatric disease or occasionally related to patients with obesity and other eating disorders 7. Trophoblastic neoplasms, thought to result from high levels of hCG secretion, which, because of its structural similarity to TSH, causes "spillover" of action at the TSHR level; 8. "Inappropriate" secretion of TSH, which may be present either in patients with TSH- producing pituitary tumors (TSHomas) or from a non-neoplastic cause, i.e. pituitary resistance to the action of thyroid hormone (3,4)

Hypothyroid states include but are not restricted to: 1. Primary (or thyroidal) hypothyroidism, usually resulting from auto-antibodies to thyroid proteins, such as antimicrosomal antibodies to TPO usually associated with lymphocytic (Hashimoto's) thyroiditis (HT) or atrophic thyroiditis, or blocking antibodies to the TSHR, usually in the context of non-goitrous hypothyroidism; 2. Secondary (or pituitary) hypothyroidism, usually resulting from tumors of the pituitary of non-thyrotropic origin such, as growth hormone (GH)-secreting tumors or prolactinomas; 3. Tertiary (or hypothalamic) hypothyroidism, usually resulting from a deficiency in the hypothalamic hormone thyrotropin-releasing hormone (TRH), either of unknown etiology or secondary to a pituitary tumor; 4. Bio-inactive TSH, either relating to an endogenous abnormality of hypothalamic hormones or secondary to pituitary tumors (and usually related to abnormal glycosylation patterns of the TSH molecule); 5. Generalized resistance to thyroid hormone (RTH), a disease which has been shown to be due to abnormalities in the TH receptor, c-erbA-beta (or TR- beta)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps

Recruiting

One Study Center