Status:
COMPLETED
Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Lead Sponsor:
Centre Francois Baclesse
Collaborating Sponsors:
Fondation avenir
laboratoire Genzyme
Conditions:
Thyroid Node
Indeterminate Cytology
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01880203
Start Date
May 1 2013
End Date
November 1 2015
Last Update
October 21 2016
Active Locations (4)
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1
Centre François BACLESSE
Caen, Calvados, France, 14000
2
CHU
Caen, Calvados, France, 14000
3
Hôpital Américain de Paris
Neuilly-sur-Seine, France
4
Hôpital Pitié-salpétrière
Paris, France, 75 000