Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Follow up lasting less than 3 months;
Incomplete or missing clinical data that may affect the correct assessment of the patient.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
5,850 Participants
are grouped into 2 trial groupsGroup A: Retrospective Group
Group B: Prospective Group
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov