Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma (MITICA)

National Cancer Institute, Naples

Status

Enrolling

Conditions

Papillary Microcarcinoma of the Thyroid

Treatments

Procedure: Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04129281

MITICA

Details and patient eligibility

About

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) .

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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