Study of Clinical Outcomes of Thyroid Cancer (ITCO)

May 8, 2023 updated by: Sebastiano Filetti, University of Roma La Sapienza

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • Ospedali Riuniti di Ancona
        • Contact:
          • Augusto Taccaliti, MD
      • Bari, Italy
        • Recruiting
        • Università degli Studi di Bari
        • Contact:
          • Francesco Giorgino, M.D.
        • Contact:
          • Vincenzo Triggiani, M.D.
      • Biella, Italy
        • Recruiting
        • Ospedale degli Infermi di Biella
        • Contact:
          • Anna Nelva, MD
      • Bologna, Italy
        • Recruiting
        • Azienda Unità Sanitaria di Bologna - Ospedale Maggiore
        • Contact:
          • Erica Solaroli, M.D.
        • Contact:
          • Alessandra Sforza, M.D.
      • Bologna, Italy
        • Recruiting
        • University of Bologna, S. Orsola Malpighi Hospital
        • Contact:
          • Uberto Pagotto, MD
      • Brescia, Italy
        • Recruiting
        • Università degli Studi di Brescia, Spedali Civili
        • Contact:
          • Francesco Dondi, MD
      • Cagliari, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Cagliari
        • Contact:
          • Francesco Boi, MD
      • Catanzaro, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria "Mater Domini" di Catanzaro
        • Contact:
          • Antonio Brunetti, MD
      • Ferrara, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria di Ferrara
        • Contact:
          • Maria Chiara Zatelli, MD
      • Firenze, Italy
        • Recruiting
        • University of Florence
        • Contact:
          • Luisa Petrone, MD
      • Genova, Italy
        • Recruiting
        • Ente Ospedaliero Ospedali Galliera
        • Contact:
          • Arnoldo Piccardo, MD
      • Latina, Italy
        • Recruiting
        • Sapienza University of Rome, Santa Maria Goretti Hospital
        • Contact:
          • Marco Centanni, MD
      • Matera, Italy
        • Recruiting
        • Tinchi Pisticci Hospital
        • Contact:
          • Antonella Carbone, MD
      • Messina, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria "Gaetano Martino"
        • Contact:
          • Guido Fadda, MD
      • Milan, Italy
        • Recruiting
        • Università degli Studi di Milano, Istituto Auxologico
        • Contact:
          • Laura Fugazzola, MD
        • Principal Investigator:
          • Laura Fugazzola, MD
        • Principal Investigator:
          • Luca Persani, MD
      • Modena, Italy
        • Recruiting
        • University of Modena and Reggio Emilia
        • Contact:
          • Bruno Madeo, MD
      • Napoli, Italy
        • Recruiting
        • University of Naples Federico II
        • Contact:
          • Domenico Salvatore, MD
      • Padova, Italy
        • Recruiting
        • Azienda Ospedale-Universita Padova
        • Contact:
          • Caterina Mian, MD
      • Padova, Italy
        • Not yet recruiting
        • Istituto Oncologico del Veneto IRCCS
        • Contact:
          • Stefania Zovato, MD
      • Parma, Italy
        • Recruiting
        • University of Parma
        • Contact:
          • Graziano Ceresini, MD
      • Pavia, Italy
        • Recruiting
        • Istituti Clinici Scientifici Maugeri
        • Contact:
          • Mario Rotondi, MD
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
          • Alessandro Antonelli, MD
      • Roma, Italy
        • Recruiting
        • Bio-Medical Campus University
        • Contact:
          • Anna Crescenzi, MD
      • Roma, Italy
        • Recruiting
        • Sapienza University of Rome, Sant'Andrea Hospital
        • Contact:
          • Salvatore Monti, MD
      • Roma, Italy
        • Recruiting
        • IRCCS Istituti Fisioterapici Ospitalieri - IFO - Istituto Regina Elena
        • Contact:
          • Marialuisa Appetecchia, MD
      • Rome, Italy, I-00161
      • Salerno, Italy
        • Recruiting
        • A.O.U. Ruggi d'Aragona
        • Contact:
          • Mario Vitale, MD
      • Siena, Italy
        • Recruiting
        • University of Siena
        • Contact:
          • Maria Grazia Castagna, MD
      • Torino, Italy
        • Recruiting
        • AOU Città della Salute e della Scienza
        • Contact:
          • Emanuela Arvat, MD
        • Principal Investigator:
          • Emanuela Arvat, MD
        • Principal Investigator:
          • Ezio Ghigo, MD
      • Torino, Italy
        • Recruiting
        • University of Turin, Gradenigo Hospital
        • Contact:
          • Barbara Puligheddu, MD
      • Udine, Italy
        • Recruiting
        • Azienda Sanitaria Universitaria Friuli Centrale
        • Contact:
          • Fabio Vescini, MD
    • Milano
      • Milan, Milano, Italy
        • Recruiting
        • A.S.S.T. Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Marco Boniardi, MD
      • Milan, Milano, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:
          • Maura Arosio, MD
      • Milan, Milano, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Andrea Giustina, MD
    • RM
      • Albano Laziale, RM, Italy
        • Recruiting
        • Ospedale Regina Apostolorum
        • Contact:
          • Rinaldo Guglielmi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with thyroid cancer
Patients with histologically-confirmed diagnoses of papillary, follicular, Hürthle, poorly differentiated, anaplastic, or medullary thyroid cancer
Procedure: Standard treatment
e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease persistence or recurrence
Time Frame: Up to 10 years from the primary treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease persistence after 12-18 months from the primary treatment
Time Frame: 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
Disease recurrence after 3, 5 and 10 years from the primary treatment
Time Frame: 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
Response to primary therapy
Time Frame: 1, 3, 5 and 10 years after 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
Response to secondary treatments
Time Frame: 1, 3, 5 and 10 years after therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

Catholic University of the Sacred Heart
Italian Thyroid Cancer Observatory (ITCO) Foundation

Investigators

  • Principal Investigator: Sebastiano Filetti, MD, Full professor of Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

June 25, 2019

First Submitted That Met QC Criteria

July 23, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Neoplasms

Clinical Trials on Standard treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe