The Role of Elastography in the Diagnosis of Thyroid Nodules

NCT01292044 | Completed

• 2 other identifiers: AOI/2010/VT-022010-AO1276-33
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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

Conditions

Thyroid Nodule; Thyroid Neoplasms

Keywords

elastography; cytology

Outcome Measures

Primary Outcomes (1)

• 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.

  15 days

Study Arms (1)

The study population

EXPERIMENTAL

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.

Other: Elastography

Interventions

Elastography OTHER

A conventional thyroid echography performed before a the time of fine needle aspiration will include elastographic measurements for each node under study.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Véronique Taillard, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

• Haitham Sharara, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

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: February 8, 2011
• First Posted: February 9, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

FR (1)