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NCT Number: NCT06779747

Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology

Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.

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Key information

Conditions

Hypothyroidism Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Hyperthyroidism Hyperthyroidism/Thyrotoxicosis Neoplasms Neoplasms by Site Thyroid Carcinoma Thyroid Diseases Thyroid Neoplasms Thyroid Nodule Thyroid Nodule (Benign) Thyrotoxicosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Uberto Pagotto, MD

CONTACT

[email protected]

+390512144190

Uberto Pagotto, MD

CONTACT

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Characterization of Patient Population with Thyroid Disease (Hypothyroidism, Hyperthyroidism, Benign Nodules, Thyroid Carcinoma)

    Time frame: through study completion, an average of 17 years

    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.

Secondary outcomes

  1. Comparison of L-Thyroxine Formulations (Capsules, Soft-Gel, Liquid) in Hypothyroidism Therapy

    Time frame: through study completion, an average of 17 years

    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.

  2. Comparison of L-Thyroxine + L-Thyronine Combination Therapy in Hypothyroidism

    Time frame: through study completion, an average of 17 years

    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.

  3. Evaluation of Drug-Induced Dysthyroidism

    Time frame: through study completion, an average of 17 years

    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.

  4. Impact of the Great Score on Radio-Metabolic Therapy Response in Basedow's Disease

    Time frame: through study completion, an average of 17 years

    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.

  5. 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

    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.

  6. Evaluation of Prognostic Impact of the McGill Score for Cytologically Indeterminate Thyroid Nodules

    Time frame: through study completion, an average of 17 years

    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.

  7. Evaluation of Additional Prognostic Factors for Malignancy in Thyroid Nodules

    Time frame: through study completion, an average of 17 years

    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.

  8. Efficacy and Adverse Effects of Minimally Invasive Treatments for Thyroid Nodules (Radiofrequency, Laser)

    Time frame: through study completion, an average of 17 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Uberto Pagotto, MD

CONTACT

[email protected]

+390512144190

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2021
Primary completion
2041
Study completion
2041
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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