Validation of a Multi-Genetic Test for the Diagnosis of Indeterminate Thyroid Nodules

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03061318
• Date of registration: 17/02/2017
• Prospective Registration: No
• Primary sponsor: Hernán González
• Public title: Validation of a Multi-Genetic Test for the Diagnosis of Indeterminate Thyroid Nodules CT-DS
• Scientific title: Validation of a Multi-Genetic Test for the Diagnosis of Indeterminate Thyroid Nodules
• Date of first enrolment: August 8, 2015
• Target sample size: 3100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03061318
• Study type: Observational
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Hernán E González, MD
• Affiliation: Pontificia Universidad Catolica de Chile

Key inclusion & exclusion criteria

Inclusion Criteria:

Patient = 18 years old, male or female Patent with a thyroid nodule = 8.0 mm of diameter
measured by ultrasound. Patient with indication of thyroid fine needle aspiration (FNA).
Patient with no record of spontaneous bleeding. Patient in condition to understand and sign
the ICF.

Exclusion Criteria:

1. Patient < 18 years old, male or female.

2. Patient with an ultrasound diagnosis of thyroid nodule < 8.0 mm.

3. Patient with record of spontaneous bleeding.

4. Patient with current symptoms of bleeding.

5. Patient in no condition of understanding and signing the ICF.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Indeterminate Thyroid Cytology

Primary Outcome(s)

Verify the sensitivity, specificity, NPV, PPV. [Time Frame: 30 months]

Secondary ID(s)

14-463

Source(s) of Monetary Support

Please refer to primary and secondary sponsors