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.
Study Type
OBSERVATIONAL
Enrollment
5,850
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy
RECRUITINGCharacterization 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
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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