Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

Detailed Description
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The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) . A further objective is to identify events associated with high risk of local recurrence and distant metastases. Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Official Title
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Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Conditions
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Papillary Microcarcinoma of the Thyroid

Intervention / Treatment
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* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >or =18 Suspicious nodule < or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit) Cytology consistent with the TIR4 or TIR 5 class Sieric TSH in th standard range (with or without levo-tyroxin therapy) Normal string motility to fibrolaringoscopy Written informed consent Exclusion Criteria: Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures Calcitonin increase above normal levels Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote any Contraindications to surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery<br>Surgery | Procedure: Surgery<br>* Surgery acconding to clinical practice<br>|
| No Intervention: Active surveillance<br>Follow up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in patient who received either surgery or follow up | EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) within 1 year from the diagnosis | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in patient who received either surgery or follow up | EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis | 36 months | 
| Compare the two strategies in terms of anxiety/depression | Evaluate the number of patients developing anxiety/depression (Hospital Anxiety and Depression Scale) (HADS scale, Each item on the questionnaire is scored from 0-3 and) in the two groups | 36 months | 
| Compare the two strategies in terms of adverse events | Evaluate the number of patients developing adverse events (CTCAE 5.0) | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillary Microcarcinoma of the Thyroid, Surgery, Outcome, Follow up