Indeterminate Thyroid NodulesNCT05851404
Management of Indeterminate Thyroid Nodules Across Different World Regions
An observational study of Indeterminate Thyroid Nodules, run by University of Cagliari at 1 site in Italy.
Trial summary
Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Indeterminate Thyroid Nodules
- What is being tested?
- Thyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 25 Apr 2023to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide
Who may be able to join
- Patients with Bethesda III / Bethesda IV thyroid nodules
Who cannot join
- Patients with preoperative diagnosis of lymph node metastases
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Cagliari
Cagliari, CA, 09100
Fabio Medas, MD, +393206836288, fabiomedas@unica.it
About this study
Official title: Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study
Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification[2]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.
We aim to evaluate different approaches to indeterminate nodules across different countries in the world.
- Conditions
- Indeterminate Thyroid Nodules
- Being tested
- Thyroidectomy
- Keywords
- Indeterminate thyroid nodule, Thyroid carcinoma
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThyroidectomyProcedure or surgery
Total thyroidectomy or lobectomy
| Study group | Role | What they receive |
|---|---|---|
| South East Asian Region (SEAR) | Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR Receives: Procedure: Thyroidectomy | |
| Americas Region (AMR) | Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR Receives: Procedure: Thyroidectomy | |
| Eastern Mediterranean Region (EMR) | Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR Receives: Procedure: Thyroidectomy | |
| the Europe Region (EUR) | Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR Receives: Procedure: Thyroidectomy | |
| Western Pacific Region (WPR) | Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR Receives: Procedure: Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of malignancy
Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Measured: 36 months
Surgical approach to indeterminate thyroid nodules
Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start25 Apr 2023
- Primary completion30 Jul 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indeterminate Thyroid NodulesStudies 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
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Medas, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851404
- Sponsor's protocol ID
- UNICA-MEDAS-23-01
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Indeterminate Thyroid Nodules Across Different World Regions: a Multicentric International Study
- ClinicalTrials.gov ID
- NCT05851404
- Acronym / sponsor ID
- UNICA-MEDAS-23-01
- Conditions
- Indeterminate Thyroid Nodules
- Keywords
- Indeterminate thyroid nodule, Thyroid carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 9 May 2023 (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.
Thyroid carcinoma (TC) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. The rising incidence rate of TC is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. Fine needle aspiration cytology (FNAC) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. Nevertheless, FNAC is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class III and class IV according to Bethesda Classification[2]). In fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. Thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems.
We aim to evaluate different approaches to indeterminate nodules across different countries in the world.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| South East Asian Region (SEAR) | – | Procedure: ThyroidectomyPatients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR |
| Americas Region (AMR) | – | Procedure: ThyroidectomyPatients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR |
| Eastern Mediterranean Region (EMR) | – | Procedure: ThyroidectomyPatients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR |
| the Europe Region (EUR) | – | Procedure: ThyroidectomyPatients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR |
| Western Pacific Region (WPR) | – | Procedure: ThyroidectomyPatients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide
Key inclusion criteria (1 listed)
- Patients with Bethesda III / Bethesda IV thyroid nodules
Key exclusion criteria (1 listed)
- Patients with preoperative diagnosis of lymph node 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 |
|---|---|---|
| ThyroidectomyTotal thyroidectomy or lobectomy | Procedure or surgery | Americas Region (AMR), Eastern Mediterranean Region (EMR), South East Asian Region (SEAR), Western Pacific Region (WPR), the Europe Region (EUR) |
Primary outcome
Rate of malignancy
Time frame: 36 months
Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Surgical approach to indeterminate thyroid nodules
Time frame: 36 months
Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Indeterminate Thyroid Nodules, 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 1 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of malignancy (time frame: 36 months). The study lists 2 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 May 2023.