Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Papillary Microcarcinoma of the Thyroid Clinical Trial

— MITICA  

Official title:

Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129281
• Other study ID #: MITICA
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: February 23, 2024

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: Luciano Pezzullo
• Phone: +39 0815903462
• Email: l.pezzullo[@]istitutotumori.na.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Papillary Microcarcinoma of the Thyroid
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Surgery
Surgery acconding to clinical practice

Locations

Country	Name	City	State
Italy	Istitute Nazionale Tumori - Fondazione G. Pascale	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Compare the two strategies in terms of adverse events	Evaluate the number of patients developing adverse events (CTCAE 5.0)	36 months