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Clinical Trial Summary

Nodular goiter is a highly prevalent disease in iodine-deficient areas. Usually nodule assessment includes ultrasonography (US) and fine-needle aspiration (FNA), but some benign nodules can hardly be distinguished from carcinomas. Elastography measures tissue elasticity using sonography, as malignancy is related to stiffness of solid organs. The investigators have designed a study to evaluate the diagnostic accuracy of elastography in nodular goiter. Consecutive patients will be assessed using US, FNA and elastography; the latter will be compared with cytology. Specificity, sensitivity, and predictive values will be calculated.


Clinical Trial Description

Aims:

Primary aim: to evaluate the diagnostic accuracy of elastography in thyroid nodules from a low-risk of thyroid cancer population.

Secondary aim: to evaluate the usefulness of elastography to detect carcinomas in thyroid nodules with indeterminate FNA.

Patient selection:

Inclusion criteria:

- Age > 18 yr.

- Recruitment in Endocrinology Clinics.

- Nodular goiter.

- Multinodular goiter with dominant nodule > 1 cm.

Exclusion criteria:

- Toxic nodules

- Non-accessible nodules to US or FNA

- Cystic nodules

- Nodules with calcifications in egg rind

- Contraindication for FNA ;


Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT01102127
Study type Observational
Source Castilla-León Health Service
Contact
Status Completed
Phase N/A
Start date February 2010
Completion date September 2010

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