ClinicalTrials.gg
RecruitingNCT05851404Updated May 9, 2023

Management of Indeterminate Thyroid Nodules Across Different World Regions

An observational study in Indeterminate Thyroid Nodules, sponsored by University of Cagliari. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by University of Cagliari · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2023, 3 years 3 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
10,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 58 studies in Thyroid Neoplasms with a site in Italy — 18 open to participants now, 22 under way, 1 of them phase 3. Thyroid Neoplasms · Italy.

Planned enrollment
2nd of 27
10,000 · median 144
Started
2023
with 6 others
Observational
27 of 58
13 open now
Primary completion
2023-07
later than 3 of 21 live
Registered
46th of 58
by date
Lead sponsor
4 of 58
University of Cagliari

Among the 58 studies in Thyroid Neoplasms with a site in Italy, this one is the 2nd largest by planned enrollment of the 27 observational ones that give a count, is one of 7 that started in 2023, is one of 27 observational ones, reaches primary completion later than 3 of the 21 other live ones, and was the 46th registered.

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

Browse Thyroid Neoplasms studies →

Open to participants now

18 of the 58 studies in Thyroid Neoplasms with a site in Italy are open now. Recruiting first, the newest first:

12 more — sign in →

All 18 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 152 Thyroid Neoplasms studies recruiting now, 96 (63%) set no upper age limit and 27 (18%) stop at 75 or younger; 37 take children under 18; 13 take healthy volunteers.

This study: all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 58 studies in Thyroid Neoplasms with a site in Italy, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Indeterminate Thyroid Nodules

Browse trials for

Keywords

  • Indeterminate thyroid nodule
  • Thyroid carcinoma
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We aim to investigate different approaches to indeterminate thyroid nodules across different countries worldwide

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with Bethesda III / Bethesda IV thyroid nodules

Exclusion criteria

Exclusion Criteria:

  • Patients with preoperative diagnosis of lymph node
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • South East Asian Region (SEAR)

    Patients that underwent thyroidectomy for indeterminate thyroid nodules in the SEAR

    Procedure: Thyroidectomy

  • Americas Region (AMR)

    Patients that underwent thyroidectomy for indeterminate thyroid nodules in the AMR

    Procedure: Thyroidectomy

  • Eastern Mediterranean Region (EMR)

    Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EMR

    Procedure: Thyroidectomy

  • the Europe Region (EUR)

    Patients that underwent thyroidectomy for indeterminate thyroid nodules in the EUR

    Procedure: Thyroidectomy

  • Western Pacific Region (WPR)

    Patients that underwent thyroidectomy for indeterminate thyroid nodules in the WPR

    Procedure: Thyroidectomy

Interventions

  • ProcedureThyroidectomy

    Total thyroidectomy or lobectomy

06

What researchers measure

Primary outcomes

  1. Rate of malignancy

    Number of cancers over the total patients submitted to thyroidectomy for indeterminate thyroid nodules

    Time frame: 36 months

  2. Surgical approach to indeterminate thyroid nodules

    Number of lobectomies over the total patients submitted to thyroidectomy for indeterminate thyroid nodules

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2023 (actual). Primary completion is estimated for Jul 2023, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2023
First posted
May 9, 2023
StartActual
Apr 25, 2023
Primary completionEst.
Jul 30, 2023
CompletionEst.
Sep 15, 2023
Last update
May 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05851404
Lead sponsor
University of Cagliari
Responsible party
Fabio Medas (Associate Professor, University of Cagliari) — Principal investigator
First posted
May 9, 2023
Start date
Apr 25, 2023
Primary completion
Jul 30, 2023 (estimated)
Completion
Sep 15, 2023 (estimated)
Last update
May 9, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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