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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01270425
First received: January 4, 2011
Last updated: February 27, 2013
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with SSc according to the current international classification

Criteria

Inclusion Criteria:

  • Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

  • non
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270425

Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Pnina Rotman-Pikielny, MD Meir Medical Center, Israel
  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:
Sclerosis
Thyroid Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Thyroid Nodule
Thyroiditis
Hashimoto Disease
Pathologic Processes
Endocrine System Diseases
Connective Tissue Diseases
Skin Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Thyroiditis, Autoimmune

ClinicalTrials.gov processed this record on September 18, 2014