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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Roma La Sapienza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Catholic University of the Sacred Heart
Italian Thyroid Cancer Observatory (ITCO) Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings