Study of Clinical Outcomes of Thyroid Cancer
ITCO
Multicenter, Prospective, Observational Study of Clinical Outcomes of Thyroid Cancer
1 other identifier
observational
15,000
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMay 10, 2023
May 1, 2023
12 years
June 25, 2019
May 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Disease persistence after 12-18 months from the primary treatment
12-18 months from the primary treatment
Disease recurrence after 3, 5 and 10 years from the primary treatment
3, 5 and 10 years from the primary treatment
Response to primary therapy
1, 3, 5 and 10 years after therapy
Response to secondary treatments
1, 3, 5 and 10 years after therapy
Study Arms (1)
Patients diagnosed with thyroid cancer
Patients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer
Interventions
e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance
Eligibility Criteria
Patients prospectively and consecutively diagnosed with histologically-confirmed papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer.
You may qualify if:
- 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.
You may not qualify if:
- patients referred to the recruiting centers ≥12 months from the primary treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
A.S.S.T. Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy
IRCCS Ospedale San Raffaele
Milan, Milano, Italy
Ospedale Regina Apostolorum
Albano Laziale, RM, Italy
Ospedali Riuniti di Ancona
Ancona, Italy
Università degli Studi di Bari
Bari, Italy
Ospedale degli Infermi di Biella
Biella, Italy
Azienda Unità Sanitaria di Bologna - Ospedale Maggiore
Bologna, 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
Azienda Ospedaliero Universitaria di Ferrara
Ferrara, Italy
University of Florence
Florence, Italy
Ente Ospedaliero Ospedali Galliera
Genova, Italy
Sapienza University of Rome, Santa Maria Goretti Hospital
Latina, Italy
Tinchi Pisticci Hospital
Matera, Italy
Azienda Ospedaliera Universitaria "Gaetano Martino"
Messina, 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
Azienda Ospedale-Università Padova
Padua, Italy
Istituto Oncologico del Veneto IRCCS
Padua, Italy
University of Parma
Parma, Italy
Istituti Clinici Scientifici Maugeri
Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Bio-Medical Campus University
Roma, Italy
IRCCS Istituti Fisioterapici Ospitalieri - IFO - Istituto Regina Elena
Roma, Italy
Sapienza University of Rome, Sant'Andrea Hospital
Roma, Italy
Sapienza University of Rome
Rome, I-00161, Italy
A.O.U. Ruggi d'Aragona
Salerno, Italy
University of Siena
Siena, Italy
AOU Città della Salute e della Scienza
Torino, Italy
University of Turin, Gradenigo Hospital
Torino, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy
Related Publications (5)
Lamartina L, Grani G, Arvat E, Nervo A, Zatelli MC, Rossi R, Puxeddu E, Morelli S, Torlontano M, Massa M, Bellantone R, Pontecorvi A, Montesano T, Pagano L, Daniele L, Fugazzola L, Ceresini G, Bruno R, Rossetto R, Tumino S, Centanni M, Meringolo D, Castagna MG, Salvatore D, Nicolucci A, Lucisano G, Filetti S, Durante C. 8th edition of the AJCC/TNM staging system of thyroid cancer: what to expect (ITCO#2). Endocr Relat Cancer. 2018 Mar;25(3):L7-L11. doi: 10.1530/ERC-17-0453. Epub 2017 Nov 30. No abstract available.
PMID: 29192093RESULTLamartina L, Durante C, Lucisano G, Grani G, Bellantone R, Lombardi CP, Pontecorvi A, Arvat E, Felicetti F, Zatelli MC, Rossi R, Puxeddu E, Morelli S, Torlontano M, Crocetti U, Montesano T, Giubbini R, Orlandi F, Aimaretti G, Monzani F, Attard M, Francese C, Antonelli A, Limone P, Rossetto R, Fugazzola L, Meringolo D, Bruno R, Tumino S, Ceresini G, Centanni M, Monti S, Salvatore D, Spiazzi G, Mian C, Persani L, Barbaro D, Nicolucci A, Filetti S. Are Evidence-Based Guidelines Reflected in Clinical Practice? An Analysis of Prospectively Collected Data of the Italian Thyroid Cancer Observatory. Thyroid. 2017 Dec;27(12):1490-1497. doi: 10.1089/thy.2017.0299. Epub 2017 Nov 10.
PMID: 29020892RESULTGrani G, Zatelli MC, Alfo M, Montesano T, Torlontano M, Morelli S, Deandrea M, Antonelli A, Francese C, Ceresini G, Orlandi F, Maniglia CA, Bruno R, Monti S, Santaguida MG, Repaci A, Tallini G, Fugazzola L, Monzani F, Giubbini R, Rossetto R, Mian C, Crescenzi A, Tumino D, Pagano L, Pezzullo L, Lombardi CP, Arvat E, Petrone L, Castagna MG, Spiazzi G, Salvatore D, Meringolo D, Solaroli E, Monari F, Magri F, Triggiani V, Castello R, Piazza C, Rossi R, Ferraro Petrillo U, Filetti S, Durante C. Real-World Performance of the American Thyroid Association Risk Estimates in Predicting 1-Year Differentiated Thyroid Cancer Outcomes: A Prospective Multicenter Study of 2000 Patients. Thyroid. 2021 Feb;31(2):264-271. doi: 10.1089/thy.2020.0272. Epub 2020 Jul 1.
PMID: 32475305RESULTForleo R, Grani G, Alfo M, Zilioli V, Giubbini R, Zatelli MC, Gagliardi I, Piovesan A, Ragni A, Morelli S, Puxeddu E, Pagano L, Deandrea M, Ceresini G, Torlontano M, Puligheddu B, Antonelli A, Centanni M, Fugazzola L, Spiazzi G, Monti S, Rossetto R, Monzani F, Tallini G, Crescenzi A, Sparano C, Bruno R, Repaci A, Tumino D, Pezzullo L, Lombardi CP, Ferraro Petrillo U, Filetti S, Durante C, Castagna MG. Minimal Extrathyroidal Extension in Predicting 1-Year Outcomes: A Longitudinal Multicenter Study of Low-to-Intermediate-Risk Papillary Thyroid Carcinoma (ITCO#4). Thyroid. 2021 Dec;31(12):1814-1821. doi: 10.1089/thy.2021.0248. Epub 2021 Oct 20.
PMID: 34541894RESULTGrani G, Gentili M, Siciliano F, Albano D, Zilioli V, Morelli S, Puxeddu E, Zatelli MC, Gagliardi I, Piovesan A, Nervo A, Crocetti U, Massa M, Sama MT, Mele C, Deandrea M, Fugazzola L, Puligheddu B, Antonelli A, Rossetto R, D'Amore A, Ceresini G, Castello R, Solaroli E, Centanni M, Monti S, Magri F, Bruno R, Sparano C, Pezzullo L, Crescenzi A, Mian C, Tumino D, Repaci A, Castagna MG, Triggiani V, Porcelli T, Meringolo D, Locati L, Spiazzi G, Di Dalmazi G, Anagnostopoulos A, Leonardi S, Filetti S, Durante C. A Data-Driven Approach to Refine Predictions of Differentiated Thyroid Cancer Outcomes: A Prospective Multicenter Study. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1921-1928. doi: 10.1210/clinem/dgad075.
PMID: 36795619RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastiano Filetti, MD
Full professor of Internal Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Internal Medicine
Study Record Dates
First Submitted
June 25, 2019
First Posted
July 24, 2019
Study Start
January 1, 2013
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
May 10, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share