Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology

NCT06779747 | Recruiting

• 1 other identifier: TirBo
• Study Type: observational
• Target: 5,850
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothyroidism; Hyperthyroidism/Thyrotoxicosis; Thyroid Nodule (Benign); Thyroid Carcinoma

Outcome Measures

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.

  through study completion, an average of 17 years

Secondary Outcomes (8)

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

  through study completion, an average of 17 years

• Comparison of L-Thyroxine + L-Thyronine Combination Therapy in Hypothyroidism

  through study completion, an average of 17 years

• Evaluation of Drug-Induced Dysthyroidism

  through study completion, an average of 17 years

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

  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

  through study completion, an average of 17 years

Study Arms (2)

Retrospective Group

The retrospective phase will involve about 2850 patients of whom: * 500 with hypothyroidism; * 500 suffering from hyperthyroidism/thyrotoxicosis; * 1000 affe8ed with benign thyroid nodule; * 850 suffering from thyroid carcinoma.

Prospective Group

In the prospective phase, on the other hand, about 3000 patients will be sequentially enrolled, including: * 60/year with hypothyroidism; * 60/year suffering from hyperthyroidism/thyrotoxicosis; * 100/year suffering from benign thyroid nodule; * 80/year suffering from thyroid carcinoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Follow up lasting less than 3 months;
• Incomplete or missing clinical data that may affect the correct assessment of the patient.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Hypothyroidism; Hyperthyroidism; Thyrotoxicosis; Thyroid Nodule; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Uberto Pagotto, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uberto Pagotto, MD

CONTACT

+390512144190; uberto.pagotto@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 17, 2025
• Study Start: December 30, 2021
• Primary Completion (Estimated): December 29, 2041
• Study Completion (Estimated): December 30, 2041
• Last Updated: January 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)