Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880203
Recruitment Status : Completed
First Posted : June 18, 2013
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
Fondation avenir
laboratoire Genzyme
Information provided by (Responsible Party):
Centre Francois Baclesse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 (IC)

Condition or disease Intervention/treatment Phase
Thyroid Node Indeterminate Cytology Surgery Indication Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis. Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : May 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: aspiration for Molecular Cytogenetic Analysis. Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.
Other Name: cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluate the diagnostic performance of the AMC and SWE elastography [ Time Frame: at inclusion, before surgery ]
    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.


Secondary Outcome Measures :
  1. evaluate the diagnostic performance of elastography SWE [ Time Frame: at inclusion, before surgery ]
    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.

  2. Establish a combined diagnostic score results of elastography [ Time Frame: at inclusion, before surgery ]
    Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880203


Locations
Layout table for location information
France
Centre François BACLESSE
Caen, Calvados, France, 14000
CHU
Caen, Calvados, France, 14000
Hôpital Américain de Paris
Neuilly sur seine, France
Hôpital Pitié-salpétrière
Paris, France, 75 000
Sponsors and Collaborators
Centre Francois Baclesse
Fondation avenir
laboratoire Genzyme
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01880203     History of Changes
Other Study ID Numbers: SWEETMAC
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Keywords provided by Centre Francois Baclesse:
thyroid
elastography SWE
indeterminate cytology
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Nodule
Thyroid Diseases
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms