Study of Clinical Outcomes of Thyroid Cancer

Study Overview
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Brief Summary
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The Italian Thyroid Cancer Observatory (ITCO) repository was established to collect data on thyroid cancer management in a prospective and consecutive series of newly-diagnosed patients, enrolled in centers uniformly distributed across the nation.

Detailed Description
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Little information is available on current practices in the treatment of thyroid cancer: a web-based thyroid cancer database was created to collect real-life data. The participants' network include tertiary referral centers operating at the national level, as well as smaller hospital-based units with local or regional recruitment areas.

Official Title
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Multicenter, Prospective, Observational Study of Clinical Outcomes of Thyroid Cancer

Conditions
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Thyroid Neoplasms

Intervention / Treatment
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* Procedure: Standard treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically confirmed thyroid cancer clinical follow-up including serum thyroglobulin (Tg) assays, circulating Tg antibodies, and high-resolution gray-scale and color Doppler US of the thyroid bed and cervical lymph node compartments. Additional imaging studies and/or fine-needle aspiration biopsy for cytology are ordered at the examiner's discretion in accordance with evidence-based guidelines entire follow-up at a participating clinical center. Exclusion Criteria: patients referred to the recruiting centers ≥12 months from the primary treatment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with thyroid cancer<br>Patients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer | Procedure: Standard treatment<br>* e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease persistence or recurrence | Composite event of disease persistence or recurrence during clinical follow-up, detected by any of the available imaging tools (neck sonography, computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]) | Up to 10 years from the primary treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease persistence after 12-18 months from the primary treatment | Rate of disease persistence after 12-18 months from the primary treatment, detected by any of the available imaging tools (neck sonography, radioiodine whole body scan, computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]) | 12-18 months from the primary treatment | 
| Disease recurrence after 3, 5 and 10 years from the primary treatment | Rate of disease recurrence after 3, 5 and 10 years from the primary treatment, detected by any of the available imaging tools (neck sonography, radioiodine whole body scan, computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]) | 3, 5 and 10 years from the primary treatment | 
| Response to primary therapy | Response to primary treatment, evaluated according to the American Thyroid Association guidelines response to treatment: excellent response, biochemical incomplete response, indeterminate response, or structural incomplete response (combination of serum tumor markers and imaging tools, such as neck sonography, radioiodine whole body scan, computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]) | 1, 3, 5 and 10 years after therapy | 
| Response to secondary treatments | Response to secondary treatments, evaluated according to the American Thyroid Association guidelines response to treatment: excellent response, biochemical incomplete response, indeterminate response, or structural incomplete response (combination of serum tumor markers and imaging tools, such as neck sonography, radioiodine whole body scan, computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]) | 1, 3, 5 and 10 years after therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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papillary thyroid cancer, follicular thyroid cancer, poorly differentiated thyroid cancer, anaplastic thyroid cancer, medullary thyroid cancer