Status:
UNKNOWN
Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Papillary Microcarcinoma of the Thyroid
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 23 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04129281
Start Date
January 23 2019
End Date
February 23 2024
Last Update
March 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Istitute Nazionale Tumori - Fondazione G. Pascale
Napoli, Italy