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) .
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Surgery acconding to clinical practice
Istitute Nazionale Tumori - Fondazione G. Pascale
Napoli, Italy
RECRUITINGQuality 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
Time frame: 36 months
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
Time frame: 36 months
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
Time frame: 36 months
Compare the two strategies in terms of adverse events
Evaluate the number of patients developing adverse events (CTCAE 5.0)
Time frame: 36 months
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