NCT01335828

Brief Summary

Define an ultrasound/elastography benignity criteria in strategy management of a patient population carries one or more thyroid nodules.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

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

November 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

November 10, 2010

Last Update Submit

January 24, 2013

Conditions

Thyroid Nodules

Keywords

EchographyElastographyThyroid nodulesNeedles punctionThyroid surgeryPatients with thyroids nodules

Outcome Measures

Primary Outcomes (1)

  • Defined echo/elastography benignity criteria

    For ultrasound and elastography benignity criteria which will be retained, outcome focus on cytoponctions number for benin nodules can be avoided by taking into account this benign criteria

    two and half years

Secondary Outcomes (2)

  • Evaluate the diagnostic performance of elastography ShearWave for characterization of thyroid nodules in a population of patients referred for needle biopsy or surgery nodule thyroid

    two and half years

  • Assessing the use of elastography in clinical practice

    two and half years

Study Arms (1)

echography/elastography

OTHER
Device: Medical ultrasound device (ShearWave system)

Interventions

Medical ultrasound device (ShearWave system)DEVICE

Echography (all modes) and elastography "ShearWave" system

echography/elastography

Eligibility Criteria

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

You may qualify if:

  • Patient aged over 18 years old
  • Patient affiliated to social security or similarly regime
  • Patients referred for fine needle aspiration or surgery with one or more thyroid nodules

You may not qualify if:

  • Patients with too much thyroid nodules or topography too imprecise to allow unambiguous correlation between echo/elastography data and histology/cytology data
  • Patients withan echography/elastography indications cons
  • Pregnant women and lactating mothers
  • Adult unable to express their consent
  • Ward of court or under guardianship
  • Person under legal protection
  • Person deprived of freedom by judicial or administrative decision
  • Person hospitalized without their consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Investigation Center - Technological Innovation - Inserm 803 - University Hospital France

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 10, 2010

First Posted

April 14, 2011

Study Start

November 1, 2010

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

FR(1)