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Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study (SWEETMAC)

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ClinicalTrials.gov Identifier: NCT01880203
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
Fondation avenir
laboratoire Genzyme
Information provided by (Responsible Party):
Centre Francois Baclesse

Tracking Information
First Submitted Date  ICMJE June 14, 2013
First Posted Date  ICMJE June 18, 2013
Last Update Posted Date October 21, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01880203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • evaluate the diagnostic performance of elastography SWE [ Time Frame: at inclusion, before surgery ]
    For elastography SWE validate decision thresholds for the parameters of elasticity of thyroid nodules, and evaluate the diagnostic performance of elastography SWE combined with those of the standard ultrasound.
  • Establish a combined diagnostic score results of elastography [ Time Frame: at inclusion, before surgery ]
    Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Official Title  ICMJE Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Thyroid Node
  • Indeterminate Cytology
  • Surgery Indication
Intervention  ICMJE Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.
Other Name: cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.
Study Arms  ICMJE Experimental: aspiration for Molecular Cytogenetic Analysis.
Intervention: Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.
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
Actual Enrollment  ICMJE
 (submitted: September 29, 2015)
140
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2013)
120
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880203
Other Study ID Numbers  ICMJE SWEETMAC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Francois Baclesse
Study Sponsor  ICMJE Centre Francois Baclesse
Collaborators  ICMJE
  • Fondation avenir
  • laboratoire Genzyme
Investigators  ICMJE Not Provided
PRS Account Centre Francois Baclesse
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP