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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Thyroid Node, Indeterminate Cytology, Surgery Indication

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the diagnostic performance of the AMC and SWE elastography

Outcome Description:

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.

Outcome Time Frame:

at inclusion, before surgery

Safety Issue:

No

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

SWEETMAC

NCT ID:

NCT01880203

Start Date:

May 2013

Completion Date:

November 2014

Related Keywords:

  • Thyroid Node
  • Indeterminate Cytology
  • Surgery Indication
  • thyroid
  • elastography SWE
  • indeterminate cytology
  • Thyroid Diseases
  • Thyroid Nodule

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