NCT01880203

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

June 14, 2013

Last Update Submit

October 20, 2016

Conditions

Thyroid NodeIndeterminate CytologySurgery Indication

Keywords

thyroidelastography SWEindeterminate cytology

Outcome Measures

Primary Outcomes (1)

  • 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.

    at inclusion, before surgery

Secondary Outcomes (2)

  • evaluate the diagnostic performance of elastography SWE

    at inclusion, before surgery

  • Establish a combined diagnostic score results of elastography

    at inclusion, before surgery

Study Arms (1)

aspiration for Molecular Cytogenetic Analysis.

EXPERIMENTAL
Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis.

Interventions

aspiration in thyroid node for Molecular Cytogenetic Analysis.PROCEDURE
Also known as: cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.
aspiration for Molecular Cytogenetic Analysis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre François BACLESSE

Caen, Calvados, 14000, France

Location

CHU

Caen, Calvados, 14000, France

Location

Hôpital Américain de Paris

Neuilly-sur-Seine, France

Location

Hôpital Pitié-salpétrière

Paris, 75 000, France

Location

Related Publications (1)

  • 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.

    PMID: 32638211DERIVED

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 18, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations

FR(4)