Actively Recruiting
Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Led by Regina Elena Cancer Institute · Updated on 2024-12-16
30
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thyroid nodules present a variable risk of malignancy depending on the cytological result obtained from the ultrasound-assisted thyroid fine needle aspiration biopsy. According to the Italian Cytology classification SIAPEC-IAP 2014, the TIR3A nodules are indeterminate nodules with a risk of malignancy lower than 10%. Clinical and instrumental follow-up is recommended in these cases, including repetition of the fine needle aspiration. A study have demonstrate the effect of a six-month treatment with a supplement containing myo-inositol and selenium on the size and elasticity of benign thyroid nodules. Our hypothesis is that the use of this supplement can determine a reduction in the size and consistency of the nodule assessed through ultrasound and elastosonography also in cytologically indeterminate (TIR3A) nodules and that treatment can reduce the cellular proliferation of these nodules assessed by immunocytochemistry. Therefore, we design a prospective randomized pilot study to assess efficacy and safety of myo-inositol and selenium in TIR3a thyroid nosules, comparing treated and untreated patients.
CONDITIONS
Official Title
Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (over 18 years old)
- Both sexes
- Thyroid nodules classified as TIR 3A based on cytological evaluation from the first fine needle aspiration biopsy
- Signed written informed consent
- Availability of material suitable for immunocytochemical analysis of Ki-67 and PCNA
You will not qualify if you...
- Diagnosed thyroid malignancies other than TIR3A
- Abnormal thyroid stimulating hormone (TSH) levels requiring L-Thyroxine treatment
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Regina Elena National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
M
Marialuisa Appetecchia, MD
CONTACT
G
Giulia Puliani, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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