Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma (MITICA)

Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

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) .

Study Overview

• Status: Recruiting
• Conditions: Papillary Microcarcinoma of the Thyroid
• Intervention / Treatment: Procedure: Surgery

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luciano Pezzullo; Phone Number: +39 0815903462; Email: l.pezzullo@istitutotumori.na.it
• Study Contact Backup: Name: Clorinda Schettino; Phone Number: +39 081 590 1791; Email: c.schettino@istitutotumori.na.it

Study Locations

• Italy
  • Napoli, Italy
    • Recruiting
    • Istitute Nazionale Tumori - Fondazione G. Pascale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Luciano Pezzullo, IRCCS Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Anticipated): January 23, 2024
• Study Completion (Anticipated): February 23, 2024

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Outcome; Follow up; Papillary Microcarcinoma of the Thyroid
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Thyroid Diseases; Thyroid Neoplasms; Carcinoma, Papillary
• Other Study ID Numbers: MITICA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No