Study of Clinical Outcomes of Thyroid Cancer
- Conditions
- Thyroid Neoplasms
- Interventions
- Procedure: Standard treatment
- Registration Number
- NCT04031339
- Lead Sponsor
- University of Roma La Sapienza
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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.
- patients referred to the recruiting centers ≥12 months from the primary treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients diagnosed with thyroid cancer Standard treatment Patients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 \[PET\])
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 \[PET\])
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 \[PET\])
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 \[PET\])
Trial Locations
- Locations (35)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Milano, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milan, Milano, Italy
Ospedale Regina Apostolorum
🇮🇹Albano Laziale, RM, Italy
Università degli Studi di Bari
🇮🇹Bari, Italy
Azienda Unità Sanitaria di Bologna - Ospedale Maggiore
🇮🇹Bologna, Italy
Ente Ospedaliero Ospedali Galliera
🇮🇹Genova, Italy
Tinchi Pisticci Hospital
🇮🇹Matera, Italy
Azienda Ospedaliera Universitaria "Gaetano Martino"
🇮🇹Messina, Italy
University of Parma
🇮🇹Parma, Italy
Istituti Clinici Scientifici Maugeri
🇮🇹Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
🇮🇹Pisa, Italy
IRCCS Istituti Fisioterapici Ospitalieri - IFO - Istituto Regina Elena
🇮🇹Roma, Italy
Sapienza University of Rome
🇮🇹Rome, Italy
A.O.U. Ruggi d'Aragona
🇮🇹Salerno, Italy
AOU Città della Salute e della Scienza
🇮🇹Torino, Italy
Azienda Sanitaria Universitaria Friuli Centrale
🇮🇹Udine, Italy
Sapienza University of Rome, Sant'Andrea Hospital
🇮🇹Roma, Italy
A.S.S.T. Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Milano, Italy
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
Ospedale degli Infermi di Biella
🇮🇹Biella, Italy
University of Bologna, S. Orsola Malpighi Hospital
🇮🇹Bologna, Italy
Università degli Studi di Brescia, Spedali Civili
🇮🇹Brescia, Italy
Azienda Ospedaliero-Universitaria di Cagliari
🇮🇹Cagliari, Italy
Azienda Ospedaliero Universitaria "Mater Domini" di Catanzaro
🇮🇹Catanzaro, Italy
University of Florence
🇮🇹Firenze, Italy
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Ferrara, Italy
Sapienza University of Rome, Santa Maria Goretti Hospital
🇮🇹Latina, Italy
Azienda Ospedale-Università Padova
🇮🇹Padova, Italy
Università degli Studi di Milano, Istituto Auxologico
🇮🇹Milan, Italy
University of Modena and Reggio Emilia
🇮🇹Modena, Italy
University of Naples Federico II
🇮🇹Napoli, Italy
Istituto Oncologico del Veneto IRCCS
🇮🇹Padova, Italy
Bio-Medical Campus University
🇮🇹Roma, Italy
University of Siena
🇮🇹Siena, Italy
University of Turin, Gradenigo Hospital
🇮🇹Torino, Italy