Thyroid CarcinomaATCEUNCT05796960
European Multicenter Study on Surgical Management of Advanced Thyroid Cancer
An observational study of Thyroid Carcinoma and Thyroid Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma, Thyroid Cancer, Thyroid Neoplasms
- What is being tested?
- Thyroidectomy with or without lymphadenectomy or multivisceral resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 3,917 participants
- Where
- 1 siteItaly
- Study dates
- 15 Dec 2022to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with final histology of advanced thyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021
Who may be able to join
- 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
Who cannot join
- Patients <18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Luca Sessa, Dr, 34045218 ext. +39, luca.sessa@policlinicogemelli.it
Francesco Pennestrì, Dr, 3280244528 ext. +39, francesco.pennestri@policlinicogemelli.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Carcinoma, Thyroid Cancer, Thyroid Neoplasms, Thyroid Cancer, Papillary, Thyroid Cancer, Follicular, Thyroid Medullary Carcinoma
- Being tested
- Thyroidectomy with or without lymphadenectomy or multivisceral resection
- Keywords
- Thyroid carcinoma, Eurocrine, Surgical management, Stage IV
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary, Thyroid cancer, follicular, Carcinoma, Medullary, Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroidectomy with or without lymphadenectomy or multivisceral resectionProcedure or surgery
Lymph node dissection, as well as its surgical extension, was performed according to the surgeon's discretion. Multivisceral operations involved oesophagus, trachea and larynx.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Thyroidectomy with or without lymphadenectomy or multivisceral resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative characteristics
Descriptive analysis of surgical perioperative characteristics of patients undergoing surgery for advanced thyroid cancer in European centers.
Measured: January 2015-January 2021
Secondary outcomes (3)
Short-term clinical outcomes
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
Measured: January 2015-January 2021
Short-term clinical outcomes
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).
Measured: January 2015-January 2021
Short-term clinical outcomes
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).
Measured: January 2015-January 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Dec 2022
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,917 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Raffaelli, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796960
- Sponsor's protocol ID
- 4999
- Acronym
- ATCEU
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests will be evaluated by the Eurocrine Council
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicenter Study on Perioperative Management, Operative Strategy, Morbidity, and Outcomes of the Surgical Management of Advanced Thyroid Cancer: (EUROCRINE® Study Group).
- ClinicalTrials.gov ID
- NCT05796960
- Acronym / sponsor ID
- ATCEU / 4999
- Conditions
- Thyroid Carcinoma, Thyroid Cancer, Thyroid Neoplasms, Thyroid Cancer, Papillary, Thyroid Cancer, Follicular, Thyroid Medullary Carcinoma
- Keywords
- Thyroid carcinoma, Eurocrine, Surgical management, Stage IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,917 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical operations for advanced thyroid cancer | – | Procedure: Thyroidectomy with or without lymphadenectomy or multivisceral resectionAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with final histology of advanced thyroid carcinoma operated among European centers that participate in the Eurocrine® database between 2015 and 2021
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients <18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroidectomy with or without lymphadenectomy or multivisceral resectionLymph node dissection, as well as its surgical extension, was performed according to the surgeon's discretion. Multivisceral operations involved oesophagus, trachea and larynx. | Procedure or surgery | Surgical operations for advanced thyroid cancer |
Primary outcome
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.
3 secondary outcomes
Short-term clinical outcomes
Time frame: January 2015-January 2021
Short-term clinical outcomes
Time frame: January 2015-January 2021
Short-term clinical outcomes
Time frame: January 2015-January 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Individual participant dataSharing planned: Undecided. Reasonable requests will be evaluated by the Eurocrine Council
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Raffaelli, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Carcinoma and Thyroid Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Sessa, Dr (3934045218 ext. +39, luca.sessa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative characteristics (time frame: January 2015-January 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.