NCT05323669

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

April 5, 2022

Last Update Submit

April 5, 2022

Conditions

Thyroid CancerThyroid Nodule

Keywords

thyroid cancerthyroid nodulemiRNAmolecular testing

Outcome Measures

Primary Outcomes (1)

  • Molecular profile of thyroid nodules

    To develop a molecular profile of thyroid nodules that will allow to distinguish benign from malignant tumor

    2 years

Interventions

Molecular testingDIAGNOSTIC_TEST

Molecular testing of thyroid nodules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of the Republic of Belarus

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: NONE RETAINED

histological samples (Formalin Fixed Paraffin Embedded tumour tissue (FFPE)) fixed cytological samples

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Nodule

Interventions

Molecular Diagnostic Techniques

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic Techniques

Study Officials

  • Gennadij G Kondratenko, MD PhD Prof

    Belarusian State Medical University

    STUDY DIRECTOR

Central Study Contacts

Siarhei U Yakubouski, MD PhD

CONTACT

5032186yakub-2003@yandex.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Assistant Professor

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 12, 2022

Study Start

April 11, 2022

Primary Completion

December 29, 2023

Study Completion

December 31, 2024

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after summary data are published
Access Criteria
IPD will be shared through publications