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NCT05323669 Clinical Trial

Molecular Profile of Thyroid Nodules

Thyroid Cancer Clinical Trial

— MPTN  

Official title:
Study of Molecular-genetic Profile of Thyroid Nodules

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05323669
Other study ID # 20220367
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 11, 2022
Est. completion date December 31, 2024

Study information
Verified date April 2022
Source Belarusian State Medical University
Contact Siarhei U Yakubouski, MD PhD
Phone 5032186
Email yakub-2003@yandex.ru
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date December 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Molecular testing
Molecular testing of thyroid nodules

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Belarusian State Medical University Minsk City Clinical Oncologic Centre, The Institute of Genetics and Cytology National Academy of Sciences of Belarus

Outcome
Type Measure Description Time frame Safety issue
Primary Molecular profile of thyroid nodules To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor 2 years
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