Clinical trial NCT05796960: European Multicenter Study on Surgical Management of Advanced Thyroid Cancer
Official title: European Multicenter Study on Perioperative Management, Operative Strategy, Morbidity, and Outcomes of the Surgical Management of Advanced Thyroid Cancer: (EUROCRINE® Study Group).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Carcinoma
Thyroid Cancer
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Cancer, Follicular
Thyroid Medullary Carcinoma
Anaplastic Thyroid Cancer
Keywords: Thyroid carcinoma
Eurocrine
Surgical management
Stage IV
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 3917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perioperative characteristics
timeFrame: January 2015-January 2021
Secondary outcomes:
measure: Short-term clinical outcomes
timeFrame: January 2015-January 2021
measure: Short-term clinical outcomes
timeFrame: January 2015-January 2021
measure: Short-term clinical outcomes
timeFrame: January 2015-January 2021
Other outcomes:
measure: Overall survival, recurrence and mortality
timeFrame: January 2015-January 2021
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Marco Raffaelli, Prof
role: PRINCIPAL_INVESTIGATOR
References: