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Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma (MITICA)

Primary Purpose

Papillary Microcarcinoma of the Thyroid

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Surgery

About this trial

This is an interventional treatment trial for Papillary Microcarcinoma of the Thyroid focused on measuring Papillary Microcarcinoma of the Thyroid, Surgery, Outcome, Follow up

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Istitute Nazionale Tumori - Fondazione G. PascaleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Surgery

Active surveillance

Arm Description

Surgery

Follow up

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Compare the two strategies in terms of adverse events

Evaluate the number of patients developing adverse events (CTCAE 5.0)

Full Information

NCT ID

NCT04129281

First Posted

October 15, 2019

Last Updated

March 23, 2023

Sponsor

National Cancer Institute, Naples

1. Study Identification

Unique Protocol Identification Number

NCT04129281

Brief Title

Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Acronym

MITICA

Official Title

Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 23, 2019 (Actual)

Primary Completion Date

January 23, 2024 (Anticipated)

Study Completion Date

February 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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) .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Papillary Microcarcinoma of the Thyroid

Keywords

Papillary Microcarcinoma of the Thyroid, Surgery, Outcome, Follow up

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Other

Arm Description

Surgery

Arm Title

Active surveillance

Arm Type

No Intervention

Arm Description

Follow up

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Surgery acconding to clinical practice

Primary Outcome Measure Information:

Title

Quality of life in patient who received either surgery or follow up

Description

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Quality of life in patient who received either surgery or follow up

Description

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

Time Frame

36 months

Title

Compare the two strategies in terms of anxiety/depression

Description

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

Time Frame

36 months

Title

Compare the two strategies in terms of adverse events

Description

Evaluate the number of patients developing adverse events (CTCAE 5.0)

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luciano Pezzullo

Phone

+39 0815903462

l.pezzullo@istitutotumori.na.it

First Name & Middle Initial & Last Name or Official Title & Degree

Clorinda Schettino

Phone

+39 081 590 1791

c.schettino@istitutotumori.na.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luciano Pezzullo

Organizational Affiliation

IRCCS Study Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istitute Nazionale Tumori - Fondazione G. Pascale

City

Napoli

Country

Italy

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

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