Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypothyroidism, Hyperthyroidism/Thyrotoxicosis, Thyroid Nodule (Benign), Thyroid Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.
Detailed description
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.
Primary outcome measures
- Characterization of Patient Population with Thyroid Disease (Hypothyroidism, Hyperthyroidism, Benign Nodules, Thyroid Carcinoma) [Time frame: through study completion, an average of 17 years]
Secondary outcome measures (8)
- Comparison of L-Thyroxine Formulations (Capsules, Soft-Gel, Liquid) in Hypothyroidism Therapy [Time frame: through study completion, an average of 17 years]
- Comparison of L-Thyroxine + L-Thyronine Combination Therapy in Hypothyroidism [Time frame: through study completion, an average of 17 years]
- Evaluation of Drug-Induced Dysthyroidism [Time frame: through study completion, an average of 17 years]
- Impact of the Great Score on Radio-Metabolic Therapy Response in Basedow's Disease [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 [Time frame: through study completion, an average of 17 years]
- Evaluation of Prognostic Impact of the McGill Score for Cytologically Indeterminate Thyroid Nodules [Time frame: through study completion, an average of 17 years]
- Evaluation of Additional Prognostic Factors for Malignancy in Thyroid Nodules [Time frame: through study completion, an average of 17 years]
- Efficacy and Adverse Effects of Minimally Invasive Treatments for Thyroid Nodules (Radiofrequency, Laser) [Time frame: through study completion, an average of 17 years]
Eligibility criteria
Inclusion criteria
- Age older than 18 years at the time of diagnosis;
- Patients with thyroid pathology (hypothyroidism, hyperthyroidism/thyrotoxicosis, benign thyroid nodule, and thyroid carcinoma) in whom the diagnosis was made in our Center or another Center from 01/01/1995 until the approval of this study (retrospective phase) or from the time of approval of this study to the next 10 years (prospective phase);
- Obtaining informed consent.
Exclusion criteria
- Follow up lasting less than 3 months;
- Incomplete or missing clinical data that may affect the correct assessment of the patient.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06779747 · TirBo