- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05377736
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aarhus N, Denmark, 8200
- Aarhus Universityhospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Molecular testing
Descriptive and explorative study including identical molecular analyses applied to all included patients
|
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
Time Frame: Two years
|
Whole genome sequencing by next generation sequencing
|
Two years
|
RNA alterations
Time Frame: Two years
|
Total RNA sequencing including circular RNA, micro RNA and messenger RNA
|
Two years
|
DNA methylation
Time Frame: Two years
|
Whole Genome Bisulfite Sequencing
|
Two years
|
Circulating tumor DNA
Time Frame: Two years
|
Whole genome sequencing of leucocyt DNA and circularing DNA
|
Two years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristine Z Swan, Aarhus Universitetshospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Thy-sec-da 032022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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