Thyroid NoduleTHYOMICSNCT05428371
Assessment the Cancer Risk of Indeterminate Thyroid Nodules Through Integration of Clinical, Ultrasonographic and Multiomic Features
An observational study of Thyroid Nodule and Thyroid Cancer, run by University of Cagliari at 1 site in Italy.
Trial summary
Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer
- What is being tested?
- Multiomic analyses of blood and surgical specimens
- How many people
- 256 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2023to 31 Dec 2027
- Phase
- Observational
- 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
Study population: We plan to include in our study patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda classification) who have a mild risk of thyroid cancer (15-30%)
Who may be able to join
- Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)
Who cannot join
- Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
- Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
- Patients with distant metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules
Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Being tested
- Multiomic analyses of blood and surgical specimens
- Keywords
- Thyroid carcinoma, Indeterminate thyroid nodule, Genomics, Proteomics, Metabolomics
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiomic analyses of blood and surgical specimensDiagnostic test
The following items will be evaluated:
- cell free dna length and integrity
- presence or absence of SNPs in cfDNA and in DNA extracted from surgical samples
- qualitative and quantitative evaluation of serum and surgical specimens proteome (proteomics)
| Study group | Role | What they receive |
|---|---|---|
| Thyroid carcinoma | Patients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma Receives: Diagnostic Test: Multiomic analyses of blood and surgical specimens | |
| Follicular adenoma | Patients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma Receives: Diagnostic Test: Multiomic analyses of blood and surgical specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biomarkers of thyroid carcinoma
Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma
Measured: 50 months
Secondary outcomes (1)
Elaboration of diagnostic algorithm
Elanoration of diagnostic algorithm predictive of thyroid carcinoma through integration of clinical, ultrasonographic and multiomic variables able to predict che condition of thyroid cancer in patients with indeterminate thryoid nodules
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Pietro Giorgio Calò, Dott. Gian Luigi Canu
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428371
- Sponsor's protocol ID
- THYOMICS
- Acronym
- THYOMICS
- Status last verified
- Jun 2022
- First submitted
- 16 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be available under reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel, Multimodal, Machine-learning Grounded Approach to Assess the Oncological Risk of Indeterminate Thyroid Nodules
- ClinicalTrials.gov ID
- NCT05428371
- Acronym / sponsor ID
- THYOMICS / THYOMICS
- Conditions
- Thyroid Nodule, Thyroid Cancer
- Keywords
- Thyroid carcinoma, Indeterminate thyroid nodule, Genomics, Proteomics, Metabolomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Prof. Pietro Giorgio Calò, Dott. Gian Luigi Canu
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jun 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.
Indeterminate thyroid nodules have a mild risk of malignancy (15-30%). The aim of our study is to individuate new biomarkers of thyroid carcinoma through multiomic analyses of blood samples and of specimen samples of patients with indeterminate thyroid nodules.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid carcinoma | – | Diagnostic Test: Multiomic analyses of blood and surgical specimensPatients with indeterminate thyroid nodule and pathological diagnosis of thyroid carcinoma |
| Follicular adenoma | – | Diagnostic Test: Multiomic analyses of blood and surgical specimensPatients with indeterminate thyroid nodule and pathological diagnosis of follicular adenoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to include in our study patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda classification) who have a mild risk of thyroid cancer (15-30%)
Key inclusion criteria (1 listed)
- Patients with indeterminate thyroid nodules (Class III and Class IV according to Bethesda Classification of thyroid nodules)
Key exclusion criteria (3 listed)
- Patients with concomitant thyroid nodules of Bethesda Class V or Class VI
- Patients with preoperative diagnosis of lymph node metastases of central or lateral neck compartment
- Patients with distant metastases
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 |
|---|---|---|
| Multiomic analyses of blood and surgical specimensThe following items will be evaluated: * cell free dna length and integrity * presence or absence of SNPs in cfDNA and in DNA extracted from surgical samples * qualitative and quantitative evaluation of serum and surgical specimens proteome (proteomics) | Diagnostic test | Follicular adenoma, Thyroid carcinoma |
Primary outcome
Identification of biomarkers of thyroid carcinoma
Time frame: 50 months
Identification of alterations in cfDNA length and integrity, presence of SNPs in cfDNA, alterations of serum proteome predictive of thyroid carcinoma
1 secondary outcome
Elaboration of diagnostic algorithm
Time frame: 60 months
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 23 Jun 2022.
- Individual participant dataSharing planned: Undecided. Individual participant data will be available under reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Nodule and Thyroid Cancer, run by University of Cagliari at 1 site in Italy.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Jun 2022. 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 Italy. 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?
Identification of biomarkers of thyroid carcinoma (time frame: 50 months). 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 23 Jun 2022.