Thyroid NodulesPhase 2/3SWETHYNCT01335828
Elastography Interest in the Management of Thyroid Nodules
A Phase 2/3 study testing Medical ultrasound device (ShearWave system) in people with Thyroid Nodules, run by AdministrateurCIC at 1 site in France.
Trial summary
Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodules
- What is being tested?
- Medical ultrasound device (ShearWave system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France
Grenoble, 38043
About this study
Official title: "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.
- Conditions
- Thyroid Nodules
- Being tested
- Medical ultrasound device (ShearWave system)
- Keywords
- Echography, Elastography, Thyroid nodules, Needles punction, Thyroid surgery, Patients with thyroids nodules
- Medical subject headings
- Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical ultrasound device (ShearWave system)Device
Echography (all modes) and elastography "ShearWave" system
| Study group | Role | What they receive |
|---|---|---|
| echography/elastography | Other | Not described Receives: Device: Medical ultrasound device (ShearWave system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defined echo/elastography benignity criteria
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
Measured: two and half years
Secondary outcomes (2)
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
ROC curves for performance of ultrasound, elastography and their coupling, compared to the reference cytology / histology.
Measured: two and half years
Assessing the use of elastography in clinical practice
Measured: two and half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335828
- Sponsor's protocol ID
- DCIC 10 24
- Acronym
- SWETHY
- Status last verified
- Jan 2013
- First submitted
- 10 Nov 2010
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "ShearWave" Elastography Interest in the Management of Thyroid Nodules
- ClinicalTrials.gov ID
- NCT01335828
- Acronym / sponsor ID
- SWETHY / DCIC 10 24
- Conditions
- Thyroid Nodules
- Keywords
- Echography, Elastography, Thyroid nodules, Needles punction, Thyroid surgery, Patients with thyroids nodules
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| echography/elastography | Other | Device: Medical ultrasound device (ShearWave system) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical ultrasound device (ShearWave system)Echography (all modes) and elastography "ShearWave" system | Device | echography/elastography |
Primary outcome
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
2 secondary outcomes
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
Assessing the use of elastography in clinical practice
Time frame: two and half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Medical ultrasound device (ShearWave system) in people with Thyroid Nodules, run by AdministrateurCIC at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defined echo/elastography benignity criteria (time frame: two and half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.