ITCO: Study of Clinical Outcomes of Thyroid Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients diagnosed with thyroid cancer Patients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer |
Procedure: Standard treatment
e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance
|
Outcome Measures
Primary Outcome Measures
- Disease persistence or recurrence [Up to 10 years from the primary treatment]
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])
Secondary Outcome Measures
- Disease persistence after 12-18 months from the primary treatment [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])
- Disease recurrence after 3, 5 and 10 years from the primary treatment [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])
- Response to primary therapy [1, 3, 5 and 10 years after 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])
- Response to secondary treatments [1, 3, 5 and 10 years after therapy]
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])
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ospedali Riuniti di Ancona | Ancona | Italy | ||
| 2 | Università degli Studi di Bari | Bari | Italy | ||
| 3 | Azienda Unità Sanitaria di Bologna - Ospedale Maggiore | Bologna | Italy | ||
| 4 | University of Bologna, S. Orsola Malpighi Hospital | Bologna | Italy | ||
| 5 | ASST Valle Olona - Ospedale di Busto Arsizio | Busto Arsizio | Italy | ||
| 6 | University of Florence | Firenze | Italy | ||
| 7 | Ente Ospedaliero Ospedali Galliera | Genova | Italy | ||
| 8 | Sapienza University of Rome, Santa Maria Goretti Hospital | Latina | Italy | ||
| 9 | Tinchi Pisticci Hospital | Matera | Italy | ||
| 10 | University of Milan, Fondazione IRCCS, National Cancer Institute of Milan | Milano | Italy | ||
| 11 | University of Modena and Reggio Emilia | Modena | Italy | ||
| 12 | University of Naples Federico II | Napoli | Italy | ||
| 13 | University of Parma | Parma | Italy | ||
| 14 | Bio-Medical Campus University | Roma | Italy | ||
| 15 | Sapienza University of Rome, Sant'Andrea Hospital | Roma | Italy | ||
| 16 | Sapienza University of Rome | Rome | Italy | I-00161 | |
| 17 | University of Siena | Siena | Italy | ||
| 18 | University of Turin, Gradenigo Hospital | Torino | Italy | ||
| 19 | University of Turin, Molinette Hospital | Torino | Italy |
Sponsors and Collaborators
- University of Roma La Sapienza
- Italian Thyroid Cancer Observatory (ITCO) Foundation
- Catholic University of the Sacred Heart
Investigators
- Principal Investigator: Sebastiano Filetti, MD, Full professor of Internal Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 3366