Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
This study evaluates the usefulness of molecular classifier to aid the diagnosis of
 malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid
 nodule. All participants will undergo FNAB with routine cytological assessment and molecular
 testing. Patients will undergo surgery or be followed-up, according to the clinical
 guidelines. The diagnostic power of combined molecular/clinical classifier will be compared
 to prediction based on clinical features only, by investigators blinded to the final
 diagnosis of surgical assessment.
Currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment
 of fine-needle aspiration biopsy (FNAB) classified according to the Bethesda System for
 Reporting of Thyroid Cytopathology. This does not allow for the definitive diagnosis of
 cancer in significant proportion of tumors, so called indeterminate nodules (Bethesda class
 III, IV and V). These patients require surgery to establish a definitive diagnosis, leading
 to unnecessary operating procedures in at least 2/3 of subjects.

 Molecular classifiers could significantly improve thyroid preoperative diagnostics, although
 they are not optimal and provide either high specificity to the detriment of low sensitivity
 or conversely, relatively low specificity with high sensitivity. The classifiers could be
 based on gene expression or mutations present in FNAB specimen.

 In the present study the investigators plan to assess the improvement of classification power
 by molecular gene-expression-based multi-feature classifier when added to standard clinical
 parameters indicating the risk of malignancy (Bethesda class, tumor size, patient age and
 sex). Participants will undergo FNAB with prospective collection of material for molecular
 testing and simultaneous preoperative recording of all clinical parameters. The patients will
 be operated on or followed-up according to the clinical guidelines. The comparison of a
 predictive power of clinical criteria to the combined clinical-molecular classifier will be
 carried out by the group of investigators blinded to the results of final surgery.
Inclusion Criteria:

 -  a diagnosis of thyroid nodule

 -  considerable chance for surgical procedure following biopsy result

 -  patient's consent for collection of material during routine fine needle aspiration
 biopsy

 Exclusion Criteria:

 -  age below 18 years

 -  the presence of contraindications that make surgical treatment impossible

 -  prior diagnosis of thyroid cancer

 -  antithrombotic treatment except of acetylsalicylic acid or low molecular weight
 heparin at a prophylactic dose