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Thyroid NeoplasmsITCONCT04031339

Study of Clinical Outcomes of Thyroid Cancer

An observational study of Thyroid Neoplasms, run by University of Roma La Sapienza at 35 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Thyroid Neoplasms
What is being tested?
Standard treatment
Type of treatment
Surgery or procedure
How many people
15,000 participants
Where
35 sitesItaly
Study dates
1 Jan 2013to Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients prospectively and consecutively diagnosed with histologically-confirmed papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer.

Who may be able to join

  • 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.

Who cannot join

  • patients referred to the recruiting centers ≥12 months from the primary treatment

Trial locations and contacts

35 sites in 1 country.

Cosimo Durante, MD,PhD contact

cosimo.durante@uniroma1.it

Giorgio Grani, MD,PhD contact

giorgio.grani@uniroma1.it

35 sites in 1 country

Italy35 sites, 35 recruiting

  • Ospedale Regina Apostolorum

    Albano Laziale, RM

    Rinaldo Guglielmi, MD

    Recruiting

  • Ospedali Riuniti di Ancona

    Ancona

    Augusto Taccaliti, MD

    Recruiting

  • Università degli Studi di Bari

    Bari

    Francesco Giorgino, M.D.

    Vincenzo Triggiani, M.D.

    Recruiting

  • Ospedale degli Infermi di Biella

    Biella

    Anna Nelva, MD

    Recruiting

  • Azienda Unità Sanitaria di Bologna - Ospedale Maggiore

    Bologna

    Erica Solaroli, M.D.

    Alessandra Sforza, M.D.

    Recruiting

  • University of Bologna, S. Orsola Malpighi Hospital

    Bologna

    Uberto Pagotto, MD

    Recruiting

  • Università degli Studi di Brescia, Spedali Civili

    Brescia

    Francesco Dondi, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria di Cagliari

    Cagliari

    Francesco Boi, MD

    Recruiting

  • Azienda Ospedaliero Universitaria "Mater Domini" di Catanzaro

    Catanzaro

    Antonio Brunetti, MD

    Recruiting

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara

    Maria Chiara Zatelli, MD

    Recruiting

  • University of Florence

    Florence

    Luisa Petrone, MD

    Recruiting

  • Ente Ospedaliero Ospedali Galliera

    Genova

    Arnoldo Piccardo, MD

    Recruiting

  • Sapienza University of Rome, Santa Maria Goretti Hospital

    Latina

    Marco Centanni, MD

    Recruiting

  • Tinchi Pisticci Hospital

    Matera

    Antonella Carbone, MD

    Recruiting

  • Azienda Ospedaliera Universitaria "Gaetano Martino"

    Messina

    Guido Fadda, MD

    Recruiting

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

    Milan, Milano

    Marco Boniardi, MD

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Milano

    Maura Arosio, MD

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, Milano

    Andrea Giustina, MD

    Recruiting

  • Università degli Studi di Milano, Istituto Auxologico

    Milan

    Laura Fugazzola, MD

    Laura Fugazzola, MD

    Recruiting

  • University of Modena and Reggio Emilia

    Modena

    Bruno Madeo, MD

    Recruiting

  • University of Naples Federico II

    Naples

    Domenico Salvatore, MD

    Recruiting

  • Azienda Ospedale-Università Padova

    Padova

    Caterina Mian, MD

    Recruiting

  • Istituto Oncologico del Veneto IRCCS

    Padova

    Stefania Zovato, MD

    Not yet recruiting

  • University of Parma

    Parma

    Graziano Ceresini, MD

    Recruiting

  • Istituti Clinici Scientifici Maugeri

    Pavia

    Mario Rotondi, MD

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

    Alessandro Antonelli, MD

    Recruiting

  • Bio-Medical Campus University

    Roma

    Anna Crescenzi, MD

    Recruiting

  • IRCCS Istituti Fisioterapici Ospitalieri - IFO - Istituto Regina Elena

    Roma

    Marialuisa Appetecchia, MD

    Recruiting

  • Sapienza University of Rome, Sant'Andrea Hospital

    Roma

    Salvatore Monti, MD

    Recruiting

  • Sapienza University of Rome

    Rome, I-00161

    Cosimo Durante, MD, PhD, cosimo.durante@uniroma1.it

    Giorgio Grani, MD,PhD, giorgio.grani@uniroma1.it

    Recruiting

  • A.O.U. Ruggi d'Aragona

    Salerno

    Mario Vitale, MD

    Recruiting

  • University of Siena

    Siena

    Maria Grazia Castagna, MD

    Recruiting

  • AOU Città della Salute e della Scienza

    Torino

    Emanuela Arvat, MD

    Emanuela Arvat, MD

    Recruiting

  • University of Turin, Gradenigo Hospital

    Torino

    Barbara Puligheddu, MD

    Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine

    Fabio Vescini, MD

    Recruiting

Other trials in Italy

About this study

Official title: Multicenter, Prospective, Observational Study of Clinical Outcomes of Thyroid Cancer

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.

Read the 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.

Being tested
Standard treatment
Keywords
papillary thyroid cancer, follicular thyroid cancer, poorly differentiated thyroid cancer, anaplastic thyroid cancer, medullary thyroid cancer
Medical subject headings
Thyroid Neoplasms, Thyroid Cancer, Papillary, Adenocarcinoma, Follicular, Thyroid Carcinoma, Anaplastic, Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard treatmentProcedure or surgery

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

Study groups in NCT04031339
Study groupRoleWhat they receive
Patients diagnosed with thyroid cancerPatients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer
Receives: Procedure: Standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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])

    Measured: Up to 10 years from the primary treatment

Secondary outcomes (4)

  1. 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])

    Measured: 12-18 months from the primary treatment

  2. 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])

    Measured: 3, 5 and 10 years from the primary treatment

  3. 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])

    Measured: 1, 3, 5 and 10 years after therapy

  4. 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])

    Measured: 1, 3, 5 and 10 years after therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2019
  2. Study start1 Jan 2013
  3. Primary completionJan 2025 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04031339
Sponsor's protocol ID
3366
Acronym
ITCO
Status last verified
May 2023
First submitted
25 Jun 2019
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29192093

  • 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.

    PubMed 29020892

  • 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.

    PubMed 32475305

  • 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.

    PubMed 34541894

  • 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.

    PubMed 36795619

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Neoplasms, run by University of Roma La Sapienza at 35 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cosimo Durante, MD,PhD (cosimo.durante@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease persistence or recurrence (time frame: Up to 10 years from the primary treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04031339, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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