The Role of Elastography in the Diagnosis of Thyroid Nodules
Primary Purpose
Thyroid Nodule, Thyroid Neoplasms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Elastography
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodule focused on measuring elastography, cytology
Eligibility Criteria
Inclusion Criteria:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for six months of follow-up
- The patient is programmed for surgical excision of all nodules determined to be not benign according to cytological criteria
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
- The patient is breastfeeding
- The patient has a contraindication for a treatment used in this study
- The patient has a contraindication for surgical excision of his/her thyroid nodule
- The patient refused to be operated
Sites / Locations
- CHU de Nîmes - Hôpital Universitaire Carémeau
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The study population
Arm Description
The study population consists of patients for whom an echo-guided fine-needle aspiration was performed for one or more thyroid nodes, and for whom surgical node excision is required.
Outcomes
Primary Outcome Measures
The difference between AUCs for the reference diagnostic method (cytology alone)and the new (cytology + elastography) diagnostic method.
Areas under the curves are estimated using the Wilcoxon-Mann-Chitney statistic. The gold standard is determined by anatomopathological examination of the excised tumor.
Secondary Outcome Measures
Full Information
NCT ID
NCT01292044
First Posted
February 8, 2011
Last Updated
March 26, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01292044
Brief Title
The Role of Elastography in the Diagnosis of Thyroid Nodules
Official Title
The Role of Elastography in the Diagnosis of Thyroid Nodules
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the role of elastography (along with echographic and cytological data) as a diagnostic tool for thyroid cancer
Detailed Description
Ultrasound is considered the first line examination in the exploration of the thyroid nodule. Echotexture analysis often identifies nodules at risk of malignancy, but does not replace or exclude an additional cytological exploration. Cytology, although effective, also has limitations, particularly when samples are vesicular and it is difficult discern between a benign or malignant state. The creation of a noninvasive method in this context could help to avoid invasive tests or "useless" surgical procedures.
Ultrasound elastography, which assesses tissue deformability, may provide valuable information concerning benign soft tissue characteristics, whereas malignant lesions are harder in consistency. Interest in this method, already proposed for other organs, has recently increased due to the emergence of specifically created software that enables objective evaluation of the hardness of the nodule during a conventional ultrasound analysis. The main hypothesis of this study is that elastography should allow better selection of candidates for thyroid surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Thyroid Neoplasms
Keywords
elastography, 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
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The study population
Arm Type
Experimental
Arm Description
The study population consists of patients for whom an echo-guided fine-needle aspiration was performed for one or more thyroid nodes, and for whom surgical node excision is required.
Intervention Type
Other
Intervention Name(s)
Elastography
Intervention Description
A conventional thyroid echography performed before a the time of fine needle aspiration will include elastographic measurements for each node under study.
Primary Outcome Measure Information:
Title
The difference between AUCs for the reference diagnostic method (cytology alone)and the new (cytology + elastography) diagnostic method.
Description
Areas under the curves are estimated using the Wilcoxon-Mann-Chitney statistic. The gold standard is determined by anatomopathological examination of the excised tumor.
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is available for six months of follow-up
The patient is programmed for surgical excision of all nodules determined to be not benign according to cytological criteria
Exclusion Criteria:
The patient is participating in another study
The patient is in an exclusion period determined by a previous study
The patient is under judicial protection, under tutorship or curatorship
The patient refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant
The patient is breastfeeding
The patient has a contraindication for a treatment used in this study
The patient has a contraindication for surgical excision of his/her thyroid nodule
The patient refused to be operated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Taillard, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haitham Sharara, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nimes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
The Role of Elastography in the Diagnosis of Thyroid Nodules
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