Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
- Conditions
- Papillary Microcarcinoma of the Thyroid
- Interventions
- Procedure: Surgery
- Registration Number
- NCT04129281
- Lead Sponsor
- 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) .
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery Surgery Surgery
- Primary Outcome Measures
Name Time Method Quality of life in patient who received either surgery or follow up 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
Name Time Method Quality of life in patient who received either surgery or follow up 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 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 36 months Evaluate the number of patients developing adverse events (CTCAE 5.0)
Trial Locations
- Locations (1)
Istitute Nazionale Tumori - Fondazione G. Pascale
🇮🇹Napoli, Italy