Clinical trial NCT04031339: Study of Clinical Outcomes of Thyroid Cancer
Official title: Multicenter, Prospective, Observational Study of Clinical Outcomes of Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Neoplasms
Keywords: papillary thyroid cancer
follicular thyroid cancer
poorly differentiated thyroid cancer
anaplastic thyroid cancer
medullary thyroid cancer
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Italian Thyroid Cancer Observatory (ITCO) Foundation
name: Catholic University of the Sacred Heart
First posted: 2019-07-24
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prospectively and consecutively diagnosed with histologically-confirmed papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer.

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.

Eligibility 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

Primary outcomes:
measure: Disease persistence or recurrence
timeFrame: Up to 10 years from the primary treatment
Secondary outcomes:
measure: Disease persistence after 12-18 months from the primary treatment
timeFrame: 12-18 months from the primary treatment
measure: Disease recurrence after 3, 5 and 10 years from the primary treatment
timeFrame: 3, 5 and 10 years from the primary treatment
measure: Response to primary therapy
timeFrame: 1, 3, 5 and 10 years after therapy
measure: Response to secondary treatments
timeFrame: 1, 3, 5 and 10 years after therapy
Other outcomes:
Locations:
city: Milan
country: Italy
facility: A.S.S.T. Grande Ospedale Metropolitano Niguarda
state: Milano
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Milano
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Milano
city: Albano Laziale
country: Italy
facility: Ospedale Regina Apostolorum
state: RM
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Bari
country: Italy
facility: Università degli Studi di Bari
city: Biella
country: Italy
facility: Ospedale degli Infermi di Biella
city: Bologna
country: Italy
facility: Azienda Unità Sanitaria di Bologna - Ospedale Maggiore
city: Bologna
country: Italy
facility: University of Bologna, S. Orsola Malpighi Hospital
city: Brescia
country: Italy
facility: Università degli Studi di Brescia, Spedali Civili
city: Cagliari
country: Italy
facility: Azienda Ospedaliero-Universitaria di Cagliari
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero Universitaria "Mater Domini" di Catanzaro
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria di Ferrara
city: Firenze
country: Italy
facility: University of Florence
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera
city: Latina
country: Italy
facility: Sapienza University of Rome, Santa Maria Goretti Hospital
city: Matera
country: Italy
facility: Tinchi Pisticci Hospital
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria "Gaetano Martino"
city: Milan
country: Italy
facility: Università degli Studi di Milano, Istituto Auxologico
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
city: Napoli
country: Italy
facility: University of Naples Federico II
city: Padova
country: Italy
facility: Azienda Ospedale-Università Padova
city: Padova
country: Italy
facility: Istituto Oncologico del Veneto IRCCS
city: Parma
country: Italy
facility: University of Parma
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Bio-Medical Campus University
city: Roma
country: Italy
facility: IRCCS Istituti Fisioterapici Ospitalieri - IFO - Istituto Regina Elena
city: Roma
country: Italy
facility: Sapienza University of Rome, Sant'Andrea Hospital
city: Rome
country: Italy
facility: Sapienza University of Rome
city: Salerno
country: Italy
facility: A.O.U. Ruggi d'Aragona
city: Siena
country: Italy
facility: University of Siena
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
city: Torino
country: Italy
facility: University of Turin, Gradenigo Hospital
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
Study officials:
affiliation: Full professor of Internal Medicine
name: Sebastiano Filetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lamartina 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.
citation: Grani 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.
citation: Forleo 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.
citation: Grani 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.