Thyroid Nodule Gene Sequencing in a Danish Population

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thyroid Cancer; Thyroid Nodule (Diagnosis)
• Intervention / Treatment: Genetic: Molecular analyses

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universityhospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No surgical specimen available
• Purely cystic nodules

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Molecular testing; Descriptive and explorative study including identical molecular analyses applied to all included patients	Genetic: Molecular analyses; Collect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Odense University Hospital; University of Aarhus
• Investigators: Principal Investigator: Kristine Z Swan, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): January 18, 2027

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: Thy-sec-da 032022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be in accordance with Danish legislation and regulations within the area

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No