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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 (SWEETMAC)

Primary Purpose

Thyroid Node, Indeterminate Cytology, Surgery Indication

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
aspiration in thyroid node for Molecular Cytogenetic Analysis.
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thyroid Node focused on measuring thyroid, elastography SWE, indeterminate cytology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre François BACLESSE
  • CHU
  • Hôpital Américain de Paris
  • Hôpital Pitié-salpétrière

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

aspiration for Molecular Cytogenetic Analysis.

Arm Description

Outcomes

Primary Outcome Measures

Evaluate the diagnostic performance of the AMC and SWE elastography
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

evaluate the diagnostic performance of elastography SWE
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.
Establish a combined diagnostic score results of elastography
Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis

Full Information

First Posted
June 14, 2013
Last Updated
October 20, 2016
Sponsor
Centre Francois Baclesse
Collaborators
Fondation avenir, laboratoire Genzyme
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1. Study Identification

Unique Protocol Identification Number
NCT01880203
Brief 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
Acronym
SWEETMAC
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
Collaborators
Fondation avenir, laboratoire Genzyme

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Node, Indeterminate Cytology, Surgery Indication
Keywords
thyroid, elastography SWE, indeterminate cytology

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aspiration for Molecular Cytogenetic Analysis.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
aspiration in thyroid node for Molecular Cytogenetic Analysis.
Other Intervention Name(s)
cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.
Primary Outcome Measure Information:
Title
Evaluate the diagnostic performance of the AMC and SWE elastography
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.
Time Frame
at inclusion, before surgery
Secondary Outcome Measure Information:
Title
evaluate the diagnostic performance of elastography SWE
Description
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.
Time Frame
at inclusion, before surgery
Title
Establish a combined diagnostic score results of elastography
Description
Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis
Time Frame
at inclusion, before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre François BACLESSE
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
CHU
City
Caen
State/Province
Calvados
ZIP/Postal Code
14000
Country
France
Facility Name
Hôpital Américain de Paris
City
Neuilly sur seine
Country
France
Facility Name
Hôpital Pitié-salpétrière
City
Paris
ZIP/Postal Code
75 000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32638211
Citation
Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Menegaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.
Results Reference
derived

Learn more about this trial

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

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