Papillary Microcarcinoma of the Thyroid
Conditions
Keywords
Papillary Microcarcinoma of the Thyroid, Surgery, Outcome, Follow up
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.
Interventions
PROCEDURESurgery
Surgery acconding to clinical practice
Sponsors
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Contacts
Primary ContactLuciano Pezzullo
Backup ContactClorinda Schettino
Outcome results
None listed