NCT01880203CompletedNot Applicable
Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Centre Francois Baclesse4 sites in 1 country140 target enrollmentStarted: May 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 4
- Primary Endpoint
- Evaluate the diagnostic performance of the AMC and SWE elastography
Study Overview
Brief Summary
The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised
- •vesicular lesion of undetermined significance
- •follicular neoplasm or Hurthle cells
- •lesion suspicious for malignancy
- •Confirmation of indeterminate cytology (IC) replay centralized
- •Patient affiliated to a social security scheme
- •Informed consent and signed
Exclusion Criteria
- •Thyroid node <15 mm
- •Nodules coalescing preventing proper individualization of targeted nodule
- •Indeterminate cytology older than six months
- •Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology
- •Major subject to a measure of legal protection or unable to consent
- •Refusal to participate
Arms & Interventions
aspiration for Molecular Cytogenetic Analysis.
Experimental
Intervention: aspiration in thyroid node for Molecular Cytogenetic Analysis. (Procedure)
Outcomes
Primary Outcomes
Evaluate the diagnostic performance of the AMC and SWE elastography
Time Frame: at inclusion, before surgery
Evaluate the diagnostic performance of the AMC and SWE elastography in patients with a thyroid nodule CI taking as reference the histology of the nodule.
Secondary Outcomes
- evaluate the diagnostic performance of elastography SWE(at inclusion, before surgery)
- Establish a combined diagnostic score results of elastography(at inclusion, before surgery)
Investigators
Study Sites (4)
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