NCT01270425

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 28, 2013

Status Verified

March 1, 2012

Enrollment Period

11 months

First QC Date

January 4, 2011

Last Update Submit

February 27, 2013

Conditions

Systemic SclerosisHashimoto ThyroiditisThyroid Nodules

Keywords

systemic sclerosishashimoto thyroiditisthyroid nodules

Outcome Measures

Primary Outcomes (1)

  • There are no spesific outcome measures from trail

    the measures from trail are equal to vast population

    Nnone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with SSc according to the current international classification

You may qualify if:

  • Clinical diagnosis of systemic sclerosis

You may not qualify if:

  • non

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Scleroderma, SystemicHashimoto DiseaseThyroid Nodule

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesThyroiditis, AutoimmuneThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesThyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Officials

  • Pnina Rotman-Pikielny, MD

    Meir Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

November 1, 2012

Last Updated

February 28, 2013

Record last verified: 2012-03

Locations

IL(1)