European Multicenter Study on Surgical Management of Advanced Thyroid Cancer

NCT ID: NCT05796960

Last Updated: 2023-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3917 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Thyroidectomy with or without lymphadenectomy or multivisceral resection

Intervention Type PROCEDURE

Lymph node dissection, as well as its surgical extension, was performed according to the surgeon's discretion. Multivisceral operations involved oesophagus, trachea and larynx.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Raffaelli, Prof

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Sessa, Dr

Role: CONTACT

3934045218 ext. +39

Francesco Pennestrì, Dr

Role: CONTACT

3280244528 ext. +39

Facility Contacts

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Luca Sessa, Dr

Role: primary

34045218 ext. +39

Francesco Pennestrì, Dr

Role: backup

3280244528 ext. +39

Other Identifiers

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4999

Identifier Type: -

Identifier Source: org_study_id

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