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)

Centre Francois Baclesse

Status: Completed

Conditions: Indeterminate Cytology; Surgery Indication; Thyroid Node

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01880203

SWEETMAC

Details and patient eligibility

About

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)

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

aspiration for Molecular Cytogenetic Analysis.

Experimental group

Treatment:

Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.