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Papillary Thyroid CancercN0PTCNCT06439745

More Than 50% of Unifocal cN0 T1b/Small T2 Papillary Thyroid Carcinoma May Require Completion Thyroidectomy if Nodal Status is Evaluated

An observational study of Papillary Thyroid Cancer and Papillary Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In absence of nodal metastases or aggressive features, thyroid lobectomy (TL) should be preferred over total thyroidectomy (TT) for small unifocal papillary thyroid carcinoma (PTC). However, occult, despite non-microscopic (>2 mm), nodal metastases may be present in clinically node-negative (cN0) PTCs. Read more about this study

Who is it for?
Ages 18 years and older
How many people
314 participants
Where
No sites listed yet
Study dates
1 Sep 2014to 1 Feb 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent surgical treatment of papillary thyroid carcinoma at the Surgical Division of Endocrine and Metabolic Surgery of Fondazione Policlinico Universitario A. Gemelli IRCCS between September 2014 and September 2023.

Who may be able to join

  • age>18
  • classic papillary carcinoma and variants
  • clinically unifocal and intrathyroidal PTC
  • clinical tumor size >1 cm and ≤3 cm
  • no clinical evidence of LN involvement

Who cannot join

  • age < 18
  • prior head or neck irradiation
  • family history of thyroid carcinoma
  • clinical evidence of multifocality
  • extrathyroidal extension or LN metastases
  • follow-up < 6 months.

About this study

Official title: More Than 50% of the Patients With Clinically Unifocal T1b/Small T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated

In absence of nodal metastases or aggressive features, thyroid lobectomy (TL) should be preferred over total thyroidectomy (TT) for small unifocal papillary thyroid carcinoma (PTC). However, occult, despite non-microscopic (>2 mm), nodal metastases may be present in clinically node-negative (cN0) PTCs.

Among 4216 thyroidectomies for malignancy (2014-2023), 110 (2.6%) TL plus ipsilateral central neck dissection (I-CND) were scheduled for unifocal cT1b/small cT2 (<3 cm) cN0 PTCs.

Nodes frozen section examination (FSE) was performed: when positive, completion thyroidectomy (CT) was accomplished during the same procedure. In presence of aggressive pathologic features, CT was suggested within 6 months from index operation.

Read the detailed description

Papillary thyroid carcinoma (PTC) is the most common type of thyroid cancer. Although its incidence has increased in recent decades, the prognosis is excellent due to the indolent nature of the disease. Despite that, recurrence rate of PTC remains common. Nowadays, the correct extent of thyroidectomy remains controversial. However, several studies demonstrated no significant differences in terms of disease-free survival (DFS) and loco-regional recurrence (LRR) in differentiated thyroid carcinoma (DTC) > 1cm after thyroid lobectomy (TL) vs total thyroidectomy (TT). In absence of preoperative high-risk features (HRFs), the most recent NCCN and ATA guidelines consider unifocal 1-4 cm PTCs eligible for TL. However, many of HRFs are highlighted only after pathological examination: positive nodal status, aggressive tumor subtype, multifocality, microscopic extrathyroidal extension (ETE), positive margin and lymphovascular invasion (LVI).

Recent retrospective series showed that up to 59% of preoperative low risk PCTs were upgraded to higher risk category after pathological examination. Current recommendations could potentially increase the need for re-operation, in terms of completion thyroidectomy (CT) and subsequent administration of RAI in order to reduce the risk of LRR. Among the HRFs, no preoperative clinical parameter is a predictor of nodal disease. However, occult lymph node metastases (LNMs) may be found in 31-62% of patients subjected to prophylactic CND (p-CND). The risk of complications (hypoparathyroidism and laryngeal nerve injury) is the main matter against bilateral p-CND in unifocal node negative PCT. According to a recent systematic review, basing on prevalence of occult central LNM by tumor size, ipsilateral CND (I-CND) may be justified in all PTC patients. Since isolated contralateral metastases are rare, a routine use of frozen section examination (FSE) of I-CND may allow a more accurate staging with a reduction of morbidity. Although p-CND is not usually recommended in patients with clinically unifocal cT1b/T2 node negative PTC, we supposed that the evaluation of LN status through FSE of I-CND may significantly contribute to risk stratification and consequently to modulate the extension of surgical treatment.

In this retrospective study we aim to evaluate the result of this strategy to intraoperatively identify patients who may benefit from TT with bilateral CND (B-CND), reducing the need of second step CT and, theoretically, the risk of LRR.

Among 4176 patients who underwent thyroidectomy for malignancy between September 2014 and September 2023 at Fondazione Policlinico Universitario A. Gemelli - Rome, we identified 110 patients scheduled for TL plus I-CND for clinically intrathyroidal unifocal cT1b/small cT2 node negative PTC. Every patient was informed of the risks and benefits of TL and TT, based on available guidelines.

Inclusion criteria were: age>18; classic papillary carcinoma and variants; clinically unifocal and intrathyroidal PTC; clinical tumor size >1 cm and ≤3 cm; no clinical evidence of LN involvement.

Exclusion criteria were: age < 18 years; prior head or neck irradiation; family history of thyroid carcinoma; clinical evidence of multifocality, extrathyroidal extension or LN metastases; follow-up < 6 months.

Medical subject headings
Thyroid Cancer, Papillary, Carcinoma, Papillary, Thyroid Neoplasms, Lymphatic Metastasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evaluation of patients requiring total thyroidectomy

    Evaluation of histopathologic risk factors in patients with papillary thyroid carcinoma, consisting of rate of nodal metastases, aggressive variants, lympho-angioinvasion, extranodal extension, multifocalty, positive resection status, in order to tailor surgical strategy (completion thyroidectomy)

    Measured: September 2014-September 2023

Secondary outcomes (1)
  1. evaluation of disease recurrence

    Evaluation of the rate of disease recurrence among the patients' cohort

    Measured: September 2014-September 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study start1 Sep 2014
  3. Primary completion1 Sep 2023
  4. Study completion1 Feb 2024

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06439745
Sponsor's protocol ID
6584
Acronym
cN0PTC
Status last verified
Mar 2024
First submitted
7 Mar 2024
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Papillary Thyroid Cancer and Papillary Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

evaluation of patients requiring total thyroidectomy (time frame: September 2014-September 2023). 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 2 Sep 2025.

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