- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335828
Elastography Interest in the Management of Thyroid Nodules (SWETHY)
January 24, 2013 updated by: AdministrateurCIC
"ShearWave" Elastography Interest in the Management of Thyroid Nodules
Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grenoble, France, 38043
- Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: echography/elastography
|
Echography (all modes) and elastography "ShearWave" system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defined echo/elastography benignity criteria
Time Frame: two and half years
|
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
|
two and half years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.
|
two and half years
|
Assessing the use of elastography in clinical practice
Time Frame: two and half years
|
two and half years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
November 10, 2010
First Submitted That Met QC Criteria
April 13, 2011
First Posted (Estimate)
April 14, 2011
Study Record Updates
Last Update Posted (Estimate)
January 25, 2013
Last Update Submitted That Met QC Criteria
January 24, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCIC 10 24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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