Clinical trial NCT06779747: Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology
Official title: Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypothyroidism
Hyperthyroidism/Thyrotoxicosis
Thyroid Nodule (Benign)
Thyroid Carcinoma
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 5850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Characterization of Patient Population with Thyroid Disease (Hypothyroidism, Hyperthyroidism, Benign Nodules, Thyroid Carcinoma)
timeFrame: through study completion, an average of 17 years
Secondary outcomes:
measure: Comparison of L-Thyroxine Formulations (Capsules, Soft-Gel, Liquid) in Hypothyroidism Therapy
timeFrame: through study completion, an average of 17 years
measure: Comparison of L-Thyroxine + L-Thyronine Combination Therapy in Hypothyroidism
timeFrame: through study completion, an average of 17 years
measure: Evaluation of Drug-Induced Dysthyroidism
timeFrame: through study completion, an average of 17 years
measure: Impact of the Great Score on Radio-Metabolic Therapy Response in Basedow's Disease
timeFrame: through study completion, an average of 17 years
measure: Evaluation of Efficacy and Adverse Effects of Local or Systemic Drugs in Basedow's Ophthalmopathy and Pretibial Myxedema
timeFrame: through study completion, an average of 17 years
measure: Evaluation of Prognostic Impact of the McGill Score for Cytologically Indeterminate Thyroid Nodules
timeFrame: through study completion, an average of 17 years
measure: Evaluation of Additional Prognostic Factors for Malignancy in Thyroid Nodules
timeFrame: through study completion, an average of 17 years
measure: Efficacy and Adverse Effects of Minimally Invasive Treatments for Thyroid Nodules (Radiofrequency, Laser)
timeFrame: through study completion, an average of 17 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Uberto Pagotto, MD
role: PRINCIPAL_INVESTIGATOR
References: