Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis
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Purpose
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
| Condition |
|---|
|
Systemic Sclerosis Hashimoto Thyroiditis Thyroid Nodules |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Sonographic Characterization of the Thyroid Gland in Patients With Systemic Sclerosis With and Without Hashimoto Thyroiditis |
- There are no spesific outcome measures from trail [ Time Frame: Nnone ] [ Designated as safety issue: No ]the measures from trail are equal to vast population
| Enrollment: | 60 |
| Study Start Date: | January 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with SSc according to the current international classification
Inclusion Criteria:
- Clinical diagnosis of systemic sclerosis
Exclusion Criteria:
- non
Contacts and Locations More Information
No publications provided
| Responsible Party: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01270425 History of Changes |
| Other Study ID Numbers: | MMC11175-10CTIL |
| Study First Received: | January 4, 2011 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Israel: Clalit Health Services |
Keywords provided by Meir Medical Center:
|
systemic sclerosis hashimoto thyroiditis thyroid nodules |
Additional relevant MeSH terms:
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Thyroid Diseases Thyroid Nodule Thyroiditis Hashimoto Disease Thyroiditis, Autoimmune Connective Tissue Diseases Skin Diseases |
Pathologic Processes Endocrine System Diseases Thyroid Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013