Skip to main content
OpenTrials
Completed

NCT Number: NCT01880203

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroid Node Endocrine System Diseases Indeterminate Cytology Surgery Indication Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Caen, Calvados, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aspiration in thyroid node for Molecular Cytogenetic Analysis.

Procedure

Other names: cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • Fondation avenir
  • laboratoire Genzyme

Registry information

Acronym: SWEETMAC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2013
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.