Thyroid Nodule Gene Sequencing in a Danish Population

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05377736
• Other study ID #: Thy-sec-da 032022
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Nodule

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