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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01270425
Other study ID # MMC11175-10CTIL
Secondary ID
Status Completed
Phase N/A
First received January 4, 2011
Last updated February 27, 2013
Start date January 2011
Est. completion date November 2012

Study information

Verified date March 2012
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Clalit Health Services
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

- non

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary There are no spesific outcome measures from trail the measures from trail are equal to vast population Nnone No
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