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

Indeterminate Cytology Clinical Trial

— SWEETMAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880203
• Other study ID #: SWEETMAC
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: October 20, 2016
• Start date: May 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Indeterminate Cytology
• Surgery Indication
• Thyroid Diseases
• Thyroid Node
• Thyroid Nodule

Intervention

Procedure:
• aspiration in thyroid node for Molecular Cytogenetic Analysis.

Locations

Country	Name	City	State
France	Centre François BACLESSE	Caen	Calvados
France	CHU	Caen	Calvados
France	Hôpital Américain de Paris	Neuilly sur seine
France	Hôpital Pitié-salpétrière	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Centre Francois Baclesse	Fondation avenir, laboratoire Genzyme

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the diagnostic performance of the AMC and SWE elastography	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.	at inclusion, before surgery	No
Secondary	evaluate the diagnostic performance of elastography SWE	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.	at inclusion, before surgery	No
Secondary	Establish a combined diagnostic score results of elastography	Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis	at inclusion, before surgery	No