Study of Clinical Outcomes of Thyroid Cancer

Thyroid Neoplasms Clinical Trial

— ITCO  

Official title:

Multicenter, Prospective, Observational Study of Clinical Outcomes of Thyroid Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04031339
• Other study ID #: 3366
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: University of Roma La Sapienza
• Contact: Cosimo Durante, MD,PhD
• Email: cosimo.durante[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Standard treatment
e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance

Locations

Country	Name	City	State
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	Firenze
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	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	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	Padova
Italy	Istituto Oncologico del Veneto IRCCS	Padova
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
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

Sponsors (3)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Catholic University of the Sacred Heart, Italian Thyroid Cancer Observatory (ITCO) Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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, Monza — View 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 — View 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, Cresc — View 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 — View 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, Castag — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease persistence after 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])	12-18 months from the primary treatment
Secondary	Disease recurrence after 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])	3, 5 and 10 years from the primary treatment
Secondary	Response to primary 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])	1, 3, 5 and 10 years after therapy
Secondary	Response to secondary treatments	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])	1, 3, 5 and 10 years after therapy

External Links

•   ITCO Foundation homepage