An observational study in Hypothyroidism, Hyperthyroidism/Thyrotoxicosis and Thyroid Nodule (Benign), sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.
The study is observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study. This study will be offered to any patient with thyroid pathology (hypothyroidism, hyperthyroidism/thyrotoxicosis, benign thyroid nodule, and thyroid carcinoma) followed by our Center with a minimum 3-month follow-up. In the retrospective phase, patients in whom thyroid pathology was diagnosed from 01/01/1995 until the approval of this study will be enrolled, while in the prospective phase those diagnosed from the time of the approval of this study to the next 10 years will be enrolled. In both phases, each patient will be followed for a maximum duate of 20 years.
Patients participating in the study will not undergo any procedure (laboratory or instrumental examination, examination or treatment) that is beyond the scope of normal daily clinical practice. Likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's planned enrollment of 5,850 is above the median of 148 across 98 observational studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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The study population consists of patients with thyroid pathology (hypothyroidism, hyperthyroidism/thyrotoxicosis, benign thyroid nodule, and thyroid carcinoma) followed at our Center with a minimum 3-month follow-up.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The retrospective phase will involve about 2850 patients of whom: * 500 with hypothyroidism; * 500 suffering from hyperthyroidism/thyrotoxicosis; * 1000 affe8ed with benign thyroid nodule; * 850 suffering from thyroid carcinoma.
In the prospective phase, on the other hand, about 3000 patients will be sequentially enrolled, including: * 60/year with hypothyroidism; * 60/year suffering from hyperthyroidism/thyrotoxicosis; * 100/year suffering from benign thyroid nodule; * 80/year suffering from thyroid carcinoma.
Characterization of Patient Population with Thyroid Disease (Hypothyroidism, Hyperthyroidism, Benign Nodules, Thyroid Carcinoma)
The primary objective is to describe the characteristics of the patient population followed at our Center for any thyroid disease (hypothyroidism, hyperthyroidism/thyrotoxicosis, benign thyroid nodule, and thyroid carcinoma), through specific data collection, with the intent to improve their clinical-diagnostic-therapeutic management.
Time frame: through study completion, an average of 17 years
Comparison of L-Thyroxine Formulations (Capsules, Soft-Gel, Liquid) in Hypothyroidism Therapy
This measure will compare the clinical and laboratory improvements in hypothyroidism therapy with different formulations of L-thyroxine (capsules, soft-gel, liquid). The improvements will be assessed based on changes in thyroid function tests (e.g., TSH, T4 levels) and related clinical symptoms.
Time frame: through study completion, an average of 17 years
Comparison of L-Thyroxine + L-Thyronine Combination Therapy in Hypothyroidism
This measure will evaluate the clinical-laboratory improvements in hypothyroidism therapy using a combination of L-thyroxine and L-thyronine. The assessment will focus on changes in thyroid function (e.g., TSH, T4) and patient-reported outcomes, such as fatigue and quality of life.
Time frame: through study completion, an average of 17 years
Evaluation of Drug-Induced Dysthyroidism
This measure will assess drug-induced dysthyroidisms (hypothyroidism and hyperthyroidism) caused by various drugs, including thyrotosteroids, iodine excess, lithium, amiodarone, INF, immunomodulators, and TKIs. The assessment will include clinical evaluations and thyroid function tests (e.g., TSH, T4) to monitor drug-related thyroid changes.
Time frame: through study completion, an average of 17 years
Impact of the Great Score on Radio-Metabolic Therapy Response in Basedow's Disease
This outcome measure will evaluate the prognostic impact of the Great Score and other factors in predicting the response to radio-metabolic therapy in patients with Basedow's disease. The primary assessment will include clinical response measures such as thyroid function tests and symptom resolution.
Time frame: through study completion, an average of 17 years
Evaluation of Efficacy and Adverse Effects of Local or Systemic Drugs in Basedow's Ophthalmopathy and Pretibial Myxedema
This measure will assess the efficacy and adverse effects of local or systemic drug treatments in Basedow's ophthalmopathy and pretibial myxedema. Evaluations will include changes in symptoms (e.g., ocular signs, skin changes) and any treatment-related adverse effects.
Time frame: through study completion, an average of 17 years
Evaluation of Prognostic Impact of the McGill Score for Cytologically Indeterminate Thyroid Nodules
This outcome measure will evaluate the prognostic impact of the McGill Score in patients with cytologically indeterminate thyroid nodules. The outcome will focus on predicting malignancy risk using the McGill Score, as well as other factors, and will include follow-up biopsy and surgical outcomes.
Time frame: through study completion, an average of 17 years
Evaluation of Additional Prognostic Factors for Malignancy in Thyroid Nodules
This measure will evaluate additional prognostic factors for malignancy in thyroid nodules, including molecular markers, imaging characteristics, and other clinical factors. These will be assessed in combination with the McGill Score to predict malignancy risk.
Time frame: through study completion, an average of 17 years
Efficacy and Adverse Effects of Minimally Invasive Treatments for Thyroid Nodules (Radiofrequency, Laser)
This outcome measure will evaluate the efficacy and adverse effects of minimally invasive treatments (e.g., radiofrequency ablation, laser therapy) for thyroid nodules. The assessment will include changes in nodule size, symptoms, and any procedure-related complications.
Time frame: through study completion, an average of 17 years
Plan to share: No
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