Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

NCT04129281 | Unknown DMC

• 1 other identifier: MITICA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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) .

Conditions

Papillary Microcarcinoma of the Thyroid

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  36 months

• Compare the two strategies in terms of anxiety/depression

  36 months

• Compare the two strategies in terms of adverse events

  36 months

Study Arms (2)

Surgery

OTHER

Surgery

Procedure: Surgery

Active surveillance

NO INTERVENTION

Follow up

Interventions

Surgery PROCEDURE

Surgery acconding to clinical practice

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istitute Nazionale Tumori - Fondazione G. Pascale

Napoli, Italy

RECRUITING

MeSH Terms

Conditions

Papillary Thyroid Microcarcinoma

Interventions

Surgical Procedures, Operative

Study Officials

• Luciano Pezzullo

  IRCCS Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Pezzullo

CONTACT

+39 0815903462; l.pezzullo@istitutotumori.na.it

Clorinda Schettino

CONTACT

+39 081 590 1791; c.schettino@istitutotumori.na.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 15, 2019
• First Posted: October 16, 2019
• Study Start: January 23, 2019
• Primary Completion: January 23, 2024
• Study Completion: February 23, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)