Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma (MITICA)
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|ClinicalTrials.gov Identifier: NCT04129281|
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : March 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Papillary Microcarcinoma of the Thyroid||Procedure: Surgery||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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)|
|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|
Surgery acconding to clinical practice
No Intervention: Active surveillance
- 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
- 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
- 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
- Compare the two strategies in terms of adverse events [ Time Frame: 36 months ]Evaluate the number of patients developing adverse events (CTCAE 5.0)
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
|Contact: Luciano Pezzullo||+39 firstname.lastname@example.org|
|Contact: Clorinda Schettino||+39 081 590 email@example.com|
|Istitute Nazionale Tumori - Fondazione G. Pascale||Recruiting|
|Principal Investigator:||Luciano Pezzullo||IRCCS Study Principal Investigator|