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

Completed

• Conditions: Systemic Sclerosis; Hashimoto Thyroiditis; Thyroid Nodules

• Registration Number: NCT01270425
• Lead Sponsor: Meir Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Study First Posted: 2011-01-05
• Primary Completion: 2011-12
• Status Verified: 2012-03
• Study Completion: 2012-11
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinical diagnosis of systemic sclerosis

Exclusion Criteria

• non

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
There are no spesific outcome measures from trail	Nnone	the measures from trail are equal to vast population

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel