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Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma (MITICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129281
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

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) .

Condition or disease Intervention/treatment Phase
Papillary Microcarcinoma of the Thyroid Procedure: Surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 23, 2022
Estimated Study Completion Date : February 23, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arm Intervention/treatment
Surgery
Surgery
Procedure: Surgery
Surgery acconding to clinical practice

No Intervention: Active surveillance
Follow up



Primary Outcome Measures :
  1. Quality of life in patient who received either surgery or follow up [ Time Frame: 36 months ]
    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 :
  1. Quality of life in patient who received either surgery or follow up [ Time Frame: 36 months ]
    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

  2. Compare the two strategies in terms of anxiety/depression [ Time Frame: 36 months ]
    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

  3. Compare the two strategies in terms of adverse events [ Time Frame: 36 months ]
    Evaluate the number of patients developing adverse events (CTCAE 5.0)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129281


Contacts
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Contact: Luciano Pezzullo +39 0815903462 l.pezzullo@istitutotumori.na.it
Contact: Clorinda Schettino +39 081 590 1791 c.schettino@istitutotumori.na.it

Locations
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Italy
Istitute Nazionale Tumori - Fondazione G. Pascale Recruiting
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Luciano Pezzullo IRCCS Study Principal Investigator
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT04129281    
Other Study ID Numbers: MITICA
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute, Naples:
Papillary Microcarcinoma of the Thyroid
Surgery
Outcome
Follow up
Additional relevant MeSH terms:
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Carcinoma, Papillary
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms