Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis

Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although some reports suggest they might be more frequent in patients with SSc. Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.

The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc with and without Hashimoto's disease

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Key information

Conditions

Systemic Sclerosis Autoimmune Diseases Connective Tissue Diseases Endocrine Gland Neoplasms Endocrine System Diseases Hashimoto Disease Hashimoto Thyroiditis Head and Neck Neoplasms Immune System Diseases Neoplasms Neoplasms by Site Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Thyroid Diseases Thyroid Neoplasms Thyroid Nodule Thyroid Nodules Thyroiditis Thyroiditis, Autoimmune

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, Israel

About this study

The study protocol Fifty patients with SSc according to the current international classification will be included in the study. The patients, followed-up regularly in an out-patient clinic, will be tested for their thyroid function tests as well as the presence of thyroid auto antibodies. Clinical data will be collected from their medical records. Ultrasonographic examination of the thyroid gland will be performed by a single examiner. The gland will be characterized in detail with regards to its size and echotexture and cervical lymph nodes will be detected. The number and size of its nodules will be described as well as their echoic pattern (iso, hyperechoic or hypoechoic) calcifications (micro and macro), and borders status. Large nodules (≥ 1 cm in diameter) or with malignancy- associated characteristics will be aspirated according to current clinical practice. Treatment will be given according to the cytology diagnosis. Thyroid hormone supplementation will be recommended when thyrotropin level >8 mIU/L or according to clinical judgment of the investigators.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of systemic sclerosis

Exclusion criteria

Treatment and study plan

Primary outcomes

There are no spesific outcome measures from trail

Time frame: Nnone

the measures from trail are equal to vast population

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Sonographic Characterization of the Thyroid Gland in Patients With Systemic Sclerosis With and Without Hashimoto Thyroiditis

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Jan 5, 2011
Registry last updated: Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed