MITICA: Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Sponsor

National Cancer Institute, Naples (Other)

Overall Status

Recruiting

CT.gov ID

NCT04129281

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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) .

Condition or Disease	Intervention/Treatment	Phase
Papillary Microcarcinoma of the Thyroid	Procedure: Surgery	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Actual Study Start Date :

Jan 23, 2019

Anticipated Primary Completion Date :

Jan 23, 2022

Anticipated Study Completion Date :

Feb 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Surgery Surgery	Procedure: Surgery Surgery acconding to clinical practice
No Intervention: Active surveillance Follow up

Arm

Intervention/Treatment

Other: Surgery

Surgery

Procedure: Surgery

Surgery acconding to clinical practice

No Intervention: Active surveillance

Follow up

Outcome Measures

Primary Outcome Measures

Quality of life in patient who received either surgery or follow up [36 months]
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

Secondary Outcome Measures

Quality of life in patient who received either surgery or follow up [36 months]
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
Compare the two strategies in terms of anxiety/depression [36 months]
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
Compare the two strategies in terms of adverse events [36 months]
Evaluate the number of patients developing adverse events (CTCAE 5.0)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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