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

Not Applicable

Completed

• Conditions: Surgery Indication; Thyroid Node; Indeterminate Cytology
• Interventions: Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.

• Registration Number: NCT01880203
• Lead Sponsor: Centre Francois Baclesse

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 available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-18
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aspiration for Molecular Cytogenetic Analysis.	aspiration in thyroid node for Molecular Cytogenetic Analysis.	-

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic performance of the AMC and SWE elastography	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 Outcome Measures

Name	Time	Method
evaluate the diagnostic performance of elastography SWE	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	at inclusion, before surgery	Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis

Trial Locations

Locations (4)

Hôpital Pitié-salpétrière; 🇫🇷 Paris, France

Hôpital Américain de Paris; 🇫🇷 Neuilly sur seine, France

CHU; 🇫🇷 Caen, Calvados, France

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France