ATCEU: European Multicenter Study on Surgical Management of Advanced Thyroid Cancer

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05796960

Collaborator

(none)

3,917

Enrollment

Location

8.5

Anticipated Duration (Months)

458.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Carcinoma Thyroid Cancer Thyroid Neoplasms Thyroid Cancer, Papillary Thyroid Cancer, Follicular Thyroid Medullary Carcinoma Anaplastic Thyroid Cancer	Procedure: Thyroidectomy with or without lymphadenectomy or multivisceral resection

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 Design

Study Type:

Observational

Anticipated Enrollment :

3917 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Perioperative characteristics [January 2015-January 2021]
Descriptive analysis of surgical perioperative characteristics of patients undergoing surgery for advanced thyroid cancer in European centers.

Secondary Outcome Measures

Short-term clinical outcomes [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
Short-term clinical outcomes [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).
Short-term clinical outcomes [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).

Other Outcome Measures

Overall survival, recurrence and mortality [January 2015-January 2021]
Descriptive analysis of overall survival, recurrence and mortality in patients undergoing surgery for advanced thyroid cancer in European centers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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