Thyroid Nodule (Diagnosis)NCT05377736
Thyroid Nodule Gene Sequencing in a Danish Population
A study testing Molecular analyses in people with Thyroid Nodule (Diagnosis) and Thyroid Cancer, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule (Diagnosis), Thyroid Cancer
- What is being tested?
- Molecular analyses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2022to 18 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroid nodule >1.5 cm
- BSRTC: IV, V, og VI
Who cannot join
- No surgical specimen available
- Purely cystic nodules
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Thyroid Nodule (Diagnosis), Thyroid Cancer
- Being tested
- Molecular analyses
- Medical subject headings
- Thyroid Nodule, Disease, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular analysesGenetic
Collect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery
| Study group | Role | What they receive |
|---|---|---|
| Molecular testing | Experimental | Descriptive and explorative study including identical molecular analyses applied to all included patients Receives: Genetic: Molecular analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA alterations
Whole genome sequencing by next generation sequencing
Measured: Two years
RNA alterations
Total RNA sequencing including circular RNA, micro RNA and messenger RNA
Measured: Two years
DNA methylation
Whole Genome Bisulfite Sequencing
Measured: Two years
Circulating tumor DNA
Whole genome sequencing of leucocyt DNA and circularing DNA
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion18 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Nodule (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Odense University Hospital
- Responsible party
- Principal investigator, Kristine Zøylner Swan, Aarhus University Hospital
- Investigators
- Kristine Z Swan, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377736
- Sponsor's protocol ID
- Thy-sec-da 032022
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be in accordance with Danish legislation and regulations within the area
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Nodule Gene Sequencing in a Danish Population - A Pilot Study
- ClinicalTrials.gov ID
- NCT05377736
- Acronym / sponsor ID
- Thy-sec-da 032022
- Conditions
- Thyroid Nodule (Diagnosis), Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Odense University Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 18 Jan 2028 (estimated)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular testing | Experimental | Genetic: Molecular analysesDescriptive and explorative study including identical molecular analyses applied to all included patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Thyroid nodule >1.5 cm
- BSRTC: IV, V, og VI
Key exclusion criteria (2 listed)
- No surgical specimen available
- Purely cystic nodules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular analysesCollect thyroid tissue for molecular analysis from the histological specimen collected by routine surgery | Genetic | Molecular testing |
Primary outcome
DNA alterations
Time frame: Two years
Whole genome sequencing by next generation sequencing
RNA alterations
Time frame: Two years
Total RNA sequencing including circular RNA, micro RNA and messenger RNA
DNA methylation
Time frame: Two years
Whole Genome Bisulfite Sequencing
Circulating tumor DNA
Time frame: Two years
Whole genome sequencing of leucocyt DNA and circularing DNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. IPD will be in accordance with Danish legislation and regulations within the area
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Z Swan principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular analyses in people with Thyroid Nodule (Diagnosis) and Thyroid Cancer, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA alterations (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.