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

NCT ID: NCT01880203

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-11-30

Brief Summary

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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)

Detailed Description

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Conditions

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Thyroid Node Indeterminate Cytology Surgery Indication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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aspiration for Molecular Cytogenetic Analysis.

Group Type EXPERIMENTAL

aspiration in thyroid node for Molecular Cytogenetic Analysis.

Intervention Type PROCEDURE

Interventions

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aspiration in thyroid node for Molecular Cytogenetic Analysis.

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation avenir

UNKNOWN

Sponsor Role collaborator

laboratoire Genzyme

UNKNOWN

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre François BACLESSE

Caen, Calvados, France

Site Status

CHU

Caen, Calvados, France

Site Status

Hôpital Américain de Paris

Neuilly-sur-Seine, , France

Site Status

Hôpital Pitié-salpétrière

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32638211 (View on PubMed)

Other Identifiers

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SWEETMAC

Identifier Type: -

Identifier Source: org_study_id

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