Clinical trial · Observational
Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
Prospective Validation of the Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Thyroid Neoplasm | Thyroid Gland Neoplasm | ALIAS | 0.90 |
| Thyroid Nodule | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age, and sex) and combined classifier built on both clinical parameters and gene expression data. The population of indeterminate nodules will be defined by expert analysis of cytological samples by pathologists blinded to the outcome of surgery. Diagnostic accuracy will defined as the percentage of patients who were correctly diagnosed as benign or malignant based on the data available preoperatively.
Secondary outcomes (1)
- 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
- description
- The improvement in accuracy of classification will be compared between sole clinical criteria (Bethesda class, tumor size, age, and sex) and combined classifier built on both clinical parameters and gene expression data. All patients after surgery will be included. Tumors in patients not operated on will be considered benign after confirmation of stable tumor status at least with 24 months follow-up. Patients not operated on and with shorter follow-up will be excluded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available