Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Thyroid Node - Indeterminate Cytology - Surgery Indication
Conditions: official terms
Thyroid Diseases - Thyroid Nodule
Conditions: Keywords
thyroid, elastography SWE, indeterminate cytology
Study Type
Study Phase
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Name: aspiration in thyroid node for Molecular Cytogenetic Analysis.
Type: Procedure
Overall Status
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)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Centre François BACLESSE
Caen, Calvados, France
Status: Recruiting
Contact: Stephane BARDET, MD - s.bardet@baclesse.unicancer.fr
Caen, Calvados, France
Status: Not yet recruiting
Contact: Yves REZNIK, MD
Hôpital Américain de Paris
Neuilly sur seine, France
Status: Recruiting
Contact: Hervé MONPEYSSEN, MD - herve.monpeyssen@ahparis.org
Hôpital Pitié-salpétrière
Paris, France
Status: Recruiting
Contact: Laurence LEENHARDHT, MD - laurence.leenhardt@psl.aphp.fr
Start Date
May 2013
Completion Date
November 2015
Centre Francois Baclesse
Centre Francois Baclesse
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page