Myo-inositol and Selenium in Indeterminate Thyroid Nodules (TIR3a)
Launched by REGINA ELENA CANCER INSTITUTE · Dec 13, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a dietary supplement containing myo-inositol and selenium on thyroid nodules that are classified as TIR3A, which means they are indeterminate and have a low risk of being cancerous. The researchers want to see if this supplement can help reduce the size and firmness of these nodules over six months. Patients participating in the study will be randomly assigned to either receive the supplement or not, allowing the team to compare the results between the two groups.
To be eligible for this trial, participants must be adults over 18 years old and have a TIR3A thyroid nodule. They should also provide written consent and have samples that can be analyzed for certain markers related to cell growth. However, individuals with diagnosed thyroid cancers, certain hormonal issues, or those who are pregnant or breastfeeding will not be included in the study. If you join the trial, you can expect to have regular check-ups and tests to monitor the nodule's changes throughout the treatment period.
Gender
ALL
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
About Regina Elena Cancer Institute
The Regina Elena Cancer Institute is a leading research and treatment center dedicated to advancing oncology through innovative clinical trials and comprehensive patient care. Located in Rome, Italy, the institute is committed to enhancing cancer treatment methodologies and improving patient outcomes by fostering a collaborative environment among clinicians, researchers, and patients. With a focus on cutting-edge therapies and personalized medicine, the Regina Elena Cancer Institute plays a pivotal role in the global fight against cancer, contributing to significant breakthroughs in cancer research and treatment protocols.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Trial Officials
Marialuisa Appetecchia, MD
Principal Investigator
Regina Elena National Cancer Institute - IRCCS IFO
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported