European Multicenter Study on Surgical Management of Advanced Thyroid Cancer

Trial Title: European Multicenter Study on Surgical Management of Advanced Thyroid Cancer

NCT ID: NCT05796960

Condition: Thyroid Carcinoma
Thyroid Cancer
Thyroid Neoplasms
Thyroid Cancer, Papillary
Thyroid Cancer, Follicular
Thyroid Medullary Carcinoma
Anaplastic Thyroid Cancer

Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Carcinoma, Medullary
Thyroid Cancer, Papillary
Thyroid Diseases

Conditions: Keywords:
Thyroid carcinoma
Eurocrine
Surgical management
Stage IV

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Procedure
Intervention name: Thyroidectomy with or without lymphadenectomy or multivisceral resection
Description: 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 group label: Surgical operations for advanced thyroid cancer

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Address:
City: Rome
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Luca Sessa, Dr

Phone: 34045218

Phone ext: +39
Email: luca.sessa@policlinicogemelli.it

Contact backup:
Last name: Francesco Pennestrì, Dr

Phone: 3280244528

Phone ext: +39
Email: francesco.pennestri@policlinicogemelli.it

Start date: December 15, 2022

Completion date: September 2023

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05796960