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

Sponsor

Meir Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01270425

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis Hashimoto Thyroiditis Thyroid Nodules

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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Nov 1, 2012

Outcome Measures

Primary Outcome Measures

There are no spesific outcome measures from trail [Nnone]
the measures from trail are equal to vast population

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar Saba		Israel

Sponsors and Collaborators

Meir Medical Center

Investigators

Principal Investigator: Pnina Rotman-Pikielny, MD, Meir Medical Center, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meir Medical Center

ClinicalTrials.gov Identifier:

NCT01270425

Other Study ID Numbers:

MMC11175-10CTIL

First Posted:

Jan 5, 2011

Last Update Posted:

Feb 28, 2013

Last Verified:

Mar 1, 2012

Keywords provided by Meir Medical Center

systemic sclerosis

hashimoto thyroiditis

thyroid nodules

Additional relevant MeSH terms:

Thyroid Nodule

Scleroderma, Systemic

Study Results

No Results Posted as of Feb 28, 2013