Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology

NCT ID: NCT06779747

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5850 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2041-12-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uberto Pagotto, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Uberto Pagotto, MD

Role: CONTACT

uberto.pagotto@unibo.it

+390512144190

Facility Contacts

Uberto Pagotto, MD

Role: primary

uberto.pagotto@unibo.it

+390512144190

Uberto Pagotto, MD

Role: backup

Other Identifiers

TirBo

Identifier Type: -

Identifier Source: org_study_id