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OpenTrials
Active, Not Recruiting

NCT Number: NCT05377736

Thyroid Nodule Gene Sequencing in a Danish Population

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Thyroid Nodule (Diagnosis) Disease Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Thyroid Nodule

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus Universityhospital

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No surgical specimen available
  • Purely cystic nodules

Treatment and study plan

Molecular analyses

Genetic

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

Primary outcomes

  1. DNA alterations

    Time frame: Two years

    Whole genome sequencing by next generation sequencing

  2. RNA alterations

    Time frame: Two years

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

  3. DNA methylation

    Time frame: Two years

    Whole Genome Bisulfite Sequencing

  4. Circulating tumor DNA

    Time frame: Two years

    Whole genome sequencing of leucocyt DNA and circularing DNA

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Odense University Hospital
  • University of Aarhus

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
May 17, 2022
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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