Clinical trial NCT03392402: Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
Official title: Prospective Validation of the Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Thyroid Neoplasm
Thyroid Cancer
Keywords: Thyroid nodule
Indeterminate thyroid nodule
Molecular biopsy
Gene expression classifier
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (above 18 years old) diagnosed with a thyroid nodule, in whom the fine-needle aspiration biopsy is undertaken to establish the necessity of thyroid surgery

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy in patients with indeterminate FNAB results who undergone surgery within 6 months from biopsy
timeFrame: until surgery or 6 months from biopsy
Secondary outcomes:
measure: Diagnostic accuracy in all patients recruited to the study, who were operated on or remained in follow-up for at least 24 months from biopsy.
timeFrame: until surgery or 24 months from biopsy
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
name: Barbara Jarzab, MD, PhD
role: STUDY_CHAIR
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
name: Rafal Tarnawski, MD, PhD
role: STUDY_DIRECTOR
References: