Molecular Profile of Thyroid Nodules

Not yet recruiting

• Conditions: Thyroid Cancer; Thyroid Nodule

• Registration Number: NCT05323669
• Lead Sponsor: Belarusian State Medical University

Brief Summary

Profiling and comparative analysis of genomic alterations and miRNA expression in benign and malignant thyroid tumors using histological and cytological specimens will be performed. Obtained information is necessary to create a molecular test to refine the cancer risk of cytologically indeterminate thyroid nodules.

Detailed Description

This is an non-randomised retrospective study consisting of 2 parts. Part A. Histological specimens (formalin fixed paraffin embedded) of patients who were operated on for benign and malignant thyroid disorders will undergo molecular testing to create a molecular profile of thyroid nodules characteristic of Belarusian population.

Part B. Fixed cytological smears of indeterminate thyroid nodules (categories III, IV and V according to Bethesda scoring system) of operated patients will undergo molecular testing to evaluate the possibility and reliability of molecular testing of fixed cytological smears using available assays.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study Start: 2022-04-11
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Primary Completion: 2023-12-29
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patients operated on for malignant and benign thyroid tumors. Age is greater than or equal to 18 years old.

Exclusion Criteria

no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular profile of thyroid nodules	2 years	To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor