HypothyroidismNCT06779747
Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology
An observational study of Hypothyroidism and Hyperthyroidism/Thyrotoxicosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothyroidism, Hyperthyroidism/Thyrotoxicosis, Thyroid Nodule (Benign)
- How many people
- 5,850 participants
- Where
- 1 siteItaly
- Study dates
- 30 Dec 2021to 30 Dec 2041
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Follow up lasting less than 3 months;
- Incomplete or missing clinical data that may affect the correct assessment of the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Uberto Pagotto, MD, +390512144190, uberto.pagotto@unibo.it
Uberto Pagotto, MD
About this study
Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.
Read the 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
- Medical subject headings
- Hypothyroidism, Hyperthyroidism, Thyrotoxicosis, Thyroid Nodule, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 17 years
Secondary outcomes (8)
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.
Measured: through study completion, an average of 17 years
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.
Measured: through study completion, an average of 17 years
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.
Measured: through study completion, an average of 17 years
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.
Measured: 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
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.
Measured: through study completion, an average of 17 years
Evaluation of Prognostic Impact of the McGill Score for Cytologically Indeterminate Thyroid Nodules
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.
Measured: through study completion, an average of 17 years
Evaluation of Additional Prognostic Factors for Malignancy in Thyroid Nodules
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.
Measured: through study completion, an average of 17 years
Efficacy and Adverse Effects of Minimally Invasive Treatments for Thyroid Nodules (Radiofrequency, Laser)
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.
Measured: through study completion, an average of 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start30 Dec 2021
- Primary completion29 Dec 2041 (estimated)
- Study completion30 Dec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,850 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uberto Pagotto, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779747
- Sponsor's protocol ID
- TirBo
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology
- ClinicalTrials.gov ID
- NCT06779747
- Acronym / sponsor ID
- TirBo
- Conditions
- Hypothyroidism, Hyperthyroidism/Thyrotoxicosis, Thyroid Nodule (Benign), Thyroid Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,850 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 29 Dec 2041 (estimated)
- Study completion
- 30 Dec 2041 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Follow up lasting less than 3 months;
- Incomplete or missing clinical data that may affect the correct assessment of the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Comparison of L-Thyroxine Formulations (Capsules, Soft-Gel, Liquid) in Hypothyroidism Therapy
Time frame: through study completion, an average of 17 years
Comparison of L-Thyroxine + L-Thyronine Combination Therapy in Hypothyroidism
Time frame: through study completion, an average of 17 years
Evaluation of Drug-Induced Dysthyroidism
Time frame: through study completion, an average of 17 years
Impact of the Great Score on Radio-Metabolic Therapy Response in Basedow's Disease
Time frame: 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
Time frame: through study completion, an average of 17 years
Evaluation of Prognostic Impact of the McGill Score for Cytologically Indeterminate Thyroid Nodules
Time frame: through study completion, an average of 17 years
Evaluation of Additional Prognostic Factors for Malignancy in Thyroid Nodules
Time frame: through study completion, an average of 17 years
Efficacy and Adverse Effects of Minimally Invasive Treatments for Thyroid Nodules (Radiofrequency, Laser)
Time frame: through study completion, an average of 17 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Uberto Pagotto, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism and Hyperthyroidism/Thyrotoxicosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uberto Pagotto, MD (+390512144190, uberto.pagotto@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Patient Population with Thyroid Disease (Hypothyroidism, Hyperthyroidism, Benign Nodules, Thyroid Carcinoma) (time frame: through study completion, an average of 17 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.