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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05377736
Other study ID # Thy-sec-da 032022
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date January 18, 2027

Study information

Verified date June 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date January 18, 2027
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Thyroid nodule >1.5 cm - BSRTC: IV, V, og VI Exclusion Criteria: - No surgical specimen available - Purely cystic nodules

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Molecular analyses
Collect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery

Locations

Country Name City State
Denmark Aarhus Universityhospital Aarhus N

Sponsors (3)

Lead Sponsor Collaborator
Aarhus University Hospital Odense University Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary DNA alterations Whole genome sequencing by next generation sequencing Two years
Primary RNA alterations Total RNA sequencing including circular RNA, micro RNA and messenger RNA Two years
Primary DNA methylation Whole Genome Bisulfite Sequencing Two years
Primary Circulating tumor DNA Whole genome sequencing of leucocyt DNA and circularing DNA Two years
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