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Clinical Trials/NCT05377736
NCT05377736
Active, not recruiting
Not Applicable

Thyroid Nodule Gene Sequencing in a Danish Population - a Pilot Study

Aarhus University Hospital1 site in 1 country30 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Nodule (Diagnosis)
Sponsor
Aarhus University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Circulating tumor DNA
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

This pilot study aims at describing the prevalence and distribution of molecular alterations in thyroid nodules of benign and malignant origin at the level of DNA and RNA in a Danish population.

Patients with thyroid nodules suspected of malignancy is included prospectively.

Tissue samples are collected for molecular analyses form surgical specimens and bloodsamples, and preoperative clincial features are registered.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
January 18, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Aarhus University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Kristine Zøylner Rubeck

Principal investigator

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

  • Thyroid nodule \>1.5 cm
  • BSRTC: IV, V, og VI

Exclusion Criteria

  • No surgical specimen available
  • Purely cystic nodules

Outcomes

Primary Outcomes

Circulating tumor DNA

Time Frame: Two years

Whole genome sequencing of leucocyt DNA and circularing DNA

DNA alterations

Time Frame: Two years

Whole genome sequencing by next generation sequencing

DNA methylation

Time Frame: Two years

Whole Genome Bisulfite Sequencing

RNA alterations

Time Frame: Two years

Total RNA sequencing including circular RNA, micro RNA and messenger RNA

Study Sites (1)

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