Study of Clinical Outcomes of Thyroid Cancer

NCT ID: NCT04031339

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2025-01-31

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.

Conditions

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Thyroid Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients diagnosed with thyroid cancer

Patients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer

Standard treatment

Intervention Type PROCEDURE

e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance

Interventions

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Standard treatment

e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Italian Thyroid Cancer Observatory (ITCO) Foundation

UNKNOWN

Sponsor Role collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role collaborator

University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Sebastiano Filetti

Full Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sebastiano Filetti, MD

Role: PRINCIPAL_INVESTIGATOR

Full professor of Internal Medicine

Locations

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A.S.S.T. Grande Ospedale Metropolitano Niguarda

Milan, Milano, Italy

Site Status RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Site Status RECRUITING

Ospedale Regina Apostolorum

Albano Laziale, RM, Italy

Site Status RECRUITING

Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status RECRUITING

Università degli Studi di Bari

Bari, , Italy

Site Status RECRUITING

Ospedale degli Infermi di Biella

Biella, , Italy

Site Status RECRUITING

Azienda Unità Sanitaria di Bologna - Ospedale Maggiore

Bologna, , Italy

Site Status RECRUITING

University of Bologna, S. Orsola Malpighi Hospital

Bologna, , Italy

Site Status RECRUITING

Università degli Studi di Brescia, Spedali Civili

Brescia, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria "Mater Domini" di Catanzaro

Catanzaro, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria di Ferrara

Ferrara, , Italy

Site Status RECRUITING

University of Florence

Florence, , Italy

Site Status RECRUITING

Ente Ospedaliero Ospedali Galliera

Genova, , Italy

Site Status RECRUITING

Sapienza University of Rome, Santa Maria Goretti Hospital

Latina, , Italy

Site Status RECRUITING

Tinchi Pisticci Hospital

Matera, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria "Gaetano Martino"

Messina, , Italy

Site Status RECRUITING

Università degli Studi di Milano, Istituto Auxologico

Milan, , Italy

Site Status RECRUITING

University of Modena and Reggio Emilia

Modena, , Italy

Site Status RECRUITING

University of Naples Federico II

Napoli, , Italy

Site Status RECRUITING

Azienda Ospedale-Università Padova

Padua, , Italy

Site Status RECRUITING

Istituto Oncologico del Veneto IRCCS

Padua, , Italy

Site Status NOT_YET_RECRUITING

University of Parma

Parma, , Italy

Site Status RECRUITING

Istituti Clinici Scientifici Maugeri

Pavia, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status RECRUITING

Bio-Medical Campus University

Roma, , Italy

Site Status RECRUITING

IRCCS Istituti Fisioterapici Ospitalieri - IFO - Istituto Regina Elena

Roma, , Italy

Site Status RECRUITING

Sapienza University of Rome, Sant'Andrea Hospital

Roma, , Italy

Site Status RECRUITING

Sapienza University of Rome

Rome, , Italy

Site Status RECRUITING

A.O.U. Ruggi d'Aragona

Salerno, , Italy

Site Status RECRUITING

University of Siena

Siena, , Italy

Site Status RECRUITING

AOU Città della Salute e della Scienza

Torino, , Italy

Site Status RECRUITING

University of Turin, Gradenigo Hospital

Torino, , Italy

Site Status RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale

Udine, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Cosimo Durante, MD,PhD

Role: CONTACT

Giorgio Grani, MD,PhD

Role: CONTACT

Facility Contacts

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Marco Boniardi, MD

Role: primary

Maura Arosio, MD

Role: primary

Andrea Giustina, MD

Role: primary

Rinaldo Guglielmi, MD

Role: primary

Augusto Taccaliti, MD

Role: primary

Francesco Giorgino, M.D.

Role: primary

Vincenzo Triggiani, M.D.

Role: backup

Anna Nelva, MD

Role: primary

Erica Solaroli, M.D.

Role: primary

Alessandra Sforza, M.D.

Role: backup

Uberto Pagotto, MD

Role: primary

Francesco Dondi, MD

Role: primary

Francesco Boi, MD

Role: primary

Antonio Brunetti, MD

Role: primary

Maria Chiara Zatelli, MD

Role: primary

Luisa Petrone, MD

Role: primary

Arnoldo Piccardo, MD

Role: primary

Marco Centanni, MD

Role: primary

Antonella Carbone, MD

Role: primary

Guido Fadda, MD

Role: primary

Laura Fugazzola, MD

Role: primary

Bruno Madeo, MD

Role: primary

Domenico Salvatore, MD

Role: primary

Caterina Mian, MD

Role: primary

Stefania Zovato, MD

Role: primary

Graziano Ceresini, MD

Role: primary

Mario Rotondi, MD

Role: primary

Alessandro Antonelli, MD

Role: primary

Anna Crescenzi, MD

Role: primary

Marialuisa Appetecchia, MD

Role: primary

Salvatore Monti, MD

Role: primary

Cosimo Durante, MD, PhD

Role: primary

Giorgio Grani, MD,PhD

Role: backup

Mario Vitale, MD

Role: primary

Maria Grazia Castagna, MD

Role: primary

Emanuela Arvat, MD

Role: primary

Barbara Puligheddu, MD

Role: primary

Fabio Vescini, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 29192093 (View on PubMed)

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.

Reference Type RESULT
PMID: 29020892 (View on PubMed)

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.

Reference Type RESULT
PMID: 32475305 (View on PubMed)

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.

Reference Type RESULT
PMID: 34541894 (View on PubMed)

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.

Reference Type RESULT
PMID: 36795619 (View on PubMed)

Related Links

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http://www.itcofoundation.org

ITCO Foundation homepage

Other Identifiers

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3366

Identifier Type: -

Identifier Source: org_study_id

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