European Multicenter Study on Surgical Management of Advanced Thyroid Cancer (ATCEU)

March 31, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

European Multicenter Study on Perioperative Management, Operative Strategy, Morbidity, and Outcomes of the Surgical Management of Advanced Thyroid Cancer: (EUROCRINE® Study Group).

The main aim of the study is to evaluate peri-operative surgical characteristics, operation extent, postoperative morbidity, and outcomes in patients undergoing surgery for advanced thyroid cancer in different European centers using the EUROCRINE® database.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of thyroid cancer has risen exponentially over the last decades among developed countries. Even though this is mainly attributed to small well differentiated carcinomas (DTC) with excellent prognosis, the rates of advanced disease have also elevated. While the characteristics of advanced thyroid cancer are intuitively recognized by experienced surgeons of the field, a common definition among scientific societies is yet to be reached. The four main features of advanced cancer are locally and regionally advanced disease, distant metastasis, and recurrence. Guidelines for the optimal treatment of advanced disease are mainly included in the broader guidelines of each cancer subtype, such as the American Thyroid Association (ATA) guidelines for DTC, Medullary Thyroid Carcinoma (MTC) and most recently Anaplastic Thyroid Carcinoma (ATC). In the European setting, the European Society for Medical Oncology (ESMO) 2019 guidelines on thyroid cancer include a subsection for the management of advanced disease of each thyroid cancer type. A common limitation among published guidelines is the moderate to low level of evidence upon which the advanced disease recommendations are based; however, broad consensus has been reached regarding the paramount importance of surgery if an R0/R1 resection is achievable. Recently, new advances in targeted therapy guided by genetic alterations found in the tumor have provided new treatment options for patients; therefore, latest guidelines encourage the inclusion of patients with advanced disease in these clinical trials. Finally, neoadjuvant therapy modalities are constantly gaining ground with promising results allowing a greater portion of patients to benefit from surgery.

Study Type

Observational

Enrollment (Anticipated)

3917

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with final histology of advanced thyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021

Description

Inclusion Criteria:

  • All adult (18 years old and older) patients
  • underwent surgery
  • final histology of advanced thyroid carcinoma
  • among European centers that participate in the Eurocrine® database between 2015 and 2021

Exclusion Criteria:

  • Patients <18 years old

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical operations for advanced thyroid cancer
All adult (18 years old and older) patients registered in EUROCRINE® database with stage IV thyroid cancer, M1, N1b, or T3b and above will be included
Procedure: Thyroidectomy with or without lymphadenectomy or multivisceral resection
Lymph node dissection, as well as its surgical extension, was performed according to the surgeon's discretion. Multivisceral operations involved oesophagus, trachea and larynx.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative characteristics
Time Frame: January 2015-January 2021
Descriptive analysis of surgical perioperative characteristics of patients undergoing surgery for advanced thyroid cancer in European centers.
January 2015-January 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term clinical outcomes
Time Frame: January 2015-January 2021
Descriptive analysis of short-term clinical outcomes of patients undergoing surgery for advanced thyroid cancer in European centers in terms of RLN palsy, critical neurovascular injury and voice changes through otorhinolaryngologist and clinical post-operative evaluation
January 2015-January 2021
Short-term clinical outcomes
Time Frame: January 2015-January 2021
Descriptive analysis of short-term clinical outcomes of patients undergoing surgery for advanced thyroid cancer in European centers in terms of surgical complications, such as bleeding, lymphorrea tracheal or oesophageal injury (detected through clinical and/or imaging evaluation).
January 2015-January 2021
Short-term clinical outcomes
Time Frame: January 2015-January 2021
Descriptive analysis of short-term clinical outcomes of patients undergoing surgery for advanced thyroid cancer in European centers in terms of hypocalcemia, hypoparathormonemia (detected through clinical and/or laburatoristic evaluation).
January 2015-January 2021

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival, recurrence and mortality
Time Frame: January 2015-January 2021
Descriptive analysis of overall survival, recurrence and mortality in patients undergoing surgery for advanced thyroid cancer in European centers.
January 2015-January 2021

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Marco Raffaelli, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

December 15, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4999

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Reasonable requests will be evaluated by the Eurocrine Council

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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