Prospective Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Papillary Microcarcinoma of the Thyroid
- Sponsor
- National Cancer Institute, Naples
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Quality of life in patient who received either surgery or follow up
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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 Outcomes
- 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)