Elastography Interest in the Management of Thyroid Nodules (SWETHY)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AdministrateurCIC, University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT01335828

First received: November 10, 2010

Last updated: January 24, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 10, 2010
Last Updated Date	January 24, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2011)	Defined echo/elastography benignity criteria [ Time Frame: two and half years ] [ Designated as safety issue: Yes ] For ultrasound and elastography benignity criteria which will be retained, outcome focus on cytoponctions number for benin nodules can be avoided by taking into account this benign criteria
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01335828 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 13, 2011)	Evaluate the diagnostic performance of elastography ShearWave for characterization of thyroid nodules in a population of patients referred for needle biopsy or surgery nodule thyroid [ Time Frame: two and half years ] [ Designated as safety issue: No ] ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology. Assessing the use of elastography in clinical practice [ Time Frame: two and half years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Elastography Interest in the Management of Thyroid Nodules
Official Title ^ICMJE	"ShearWave" Elastography Interest in the Management of Thyroid Nodules
Brief Summary	Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Thyroid Nodules
Intervention ^ICMJE	Device: Medical ultrasound device (ShearWave system) Echography (all modes) and elastography "ShearWave" system
Study Arm (s)	echography/elastography Intervention: Device: Medical ultrasound device (ShearWave system)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	125
Completion Date	November 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient aged over 18 years old Patient affiliated to social security or similarly regime Patients referred for fine needle aspiration or surgery with one or more thyroid nodules Exclusion Criteria: Patients with too much thyroid nodules or topography too imprecise to allow unambiguous correlation between echo/elastography data and histology/cytology data Patients withan echography/elastography indications cons Pregnant women and lactating mothers Adult unable to express their consent Ward of court or under guardianship Person under legal protection Person deprived of freedom by judicial or administrative decision Person hospitalized without their consent
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01335828
Other Study ID Numbers ^ICMJE	DCIC 10 24
Has Data Monitoring Committee	Yes
Responsible Party	AdministrateurCIC, University Hospital, Grenoble
Study Sponsor ^ICMJE	AdministrateurCIC
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Grenoble
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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