Thyroid Nodule Gene Sequencing in a Danish Population

NCT05377736 | Active Not Recruiting DMC

• 1 other identifier: Thy-sec-da 032022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule (Diagnosis); Thyroid Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Molecular testing

EXPERIMENTAL

Descriptive and explorative study including identical molecular analyses applied to all included patients

Genetic: Molecular analyses

Interventions

Molecular analyses GENETIC

Collect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery

Molecular testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No surgical specimen available
• Purely cystic nodules

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator
• Odense University Hospital: collaborator

Study Sites (1)

Aarhus Universityhospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Thyroid Nodule; Disease; Thyroid Neoplasms

Interventions

Molecular Docking Simulation

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Models, Molecular; Models, Theoretical; Investigative Techniques

Study Officials

• Kristine Z Swan

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: May 17, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): January 18, 2027
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)