NCT05796960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,917

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

6 months

First QC Date

March 16, 2023

Last Update Submit

March 31, 2023

Conditions

Thyroid CarcinomaThyroid CancerThyroid NeoplasmsThyroid Cancer, PapillaryThyroid Cancer, FollicularThyroid Medullary CarcinomaAnaplastic Thyroid Cancer

Keywords

Thyroid carcinomaEurocrineSurgical managementStage IV

Outcome Measures

Primary Outcomes (1)

  • Perioperative characteristics

    Descriptive analysis of surgical perioperative characteristics of patients undergoing surgery for advanced thyroid cancer in European centers.

    January 2015-January 2021

Secondary Outcomes (3)

  • Short-term clinical outcomes

    January 2015-January 2021

  • Short-term clinical outcomes

    January 2015-January 2021

  • Short-term clinical outcomes

    January 2015-January 2021

Other Outcomes (1)

  • Overall survival, recurrence and mortality

    January 2015-January 2021

Study Arms (1)

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

Interventions

Thyroidectomy with or without lymphadenectomy or multivisceral resectionPROCEDURE

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

Surgical operations for advanced thyroid cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Thyroid NeoplasmsThyroid Cancer, PapillaryThyroid cancer, follicularCarcinoma, MedullaryThyroid Carcinoma, Anaplastic

Interventions

ThyroidectomyLymph Node Excision

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marco Raffaelli, Prof

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Sessa, Dr

CONTACT

3934045218luca.sessa@policlinicogemelli.it

Francesco Pennestrì, Dr

CONTACT

3280244528francesco.pennestri@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

April 4, 2023

Study Start

December 15, 2022

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

April 4, 2023

Record last verified: 2023-03

Locations

IT(1)