NCT06736015 Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
| NCT ID | NCT06736015 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Thyroid Nodule |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2027-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-10-23 with a primary completion date of 2027-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adult (\>18 years old), * both sexes, * patients presenting thyroid nodules classified as TIR 3A, based on cytological evaluation on sample from the first fine needle aspiration (FNA), * written Informed consent, * Patients with appropriate material for subsequent immunocytochemical analysis of Ki-67 and PCNA Exclusion Criteria: * Patients with diagnosed thyroid malignancies of cytological diagnosis other than TIR3A * pathological levels of the thyroid stimulating hormone (TSH) which required L-Thyroxine treatment starting * pregnancy and/or breastfeeding
Contact & Investigator
Marialuisa Appetecchia, MD
PRINCIPAL INVESTIGATOR
Regina Elena National Cancer Institute - IRCCS IFO
Frequently Asked Questions
Who can join the NCT06736015 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Nodule. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06736015 currently recruiting?
Yes, NCT06736015 is actively recruiting participants. Contact the research team at marialuisa.appetecchia@ifo.it for enrollment information.
Where is the NCT06736015 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06736015 clinical trial?
NCT06736015 is sponsored by Regina Elena Cancer Institute. The principal investigator is Marialuisa Appetecchia, MD at Regina Elena National Cancer Institute - IRCCS IFO. The trial plans to enroll 30 participants.