GETNE Registration of Thyroid Cancer

Descriptive Observational Epidemiological Study on the Characteristics of Thyroid Cancer in Patients Treated in Oncology Services of Spanish Centers: National Registry of Thyroid Cancer - Differentiated, Medullary and Anaplastic

An epidemiological, observational, multicenter, cross-sectional, retrospective study on patients ≥ 18 years visited in the oncology services of the participating centers with diagnosis of primary thyroid cancer.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Secretaria Técnica GETNE; Phone Number: +34 93 434 44 12; Email: getne@mfar.net

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitari Vall d'Hebron
    • Contact: A responsible person designated by the sponsor, M.D.; Email: investigacion@mfar.net
    • Principal Investigator: Principal investigator selected by the sponsor, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients ≥ 18 years visited in the oncology services of the participating centers that have a diagnosis of primary cancer located in the thyroid gland.

Description

Inclusion Criteria:

• Patients older than 18 years with diagnosis of differentiated, medullary or anaplastic thyroid cancer confirmed by histopathology.
• Patients who agree to participate and are able to understand the information sheet and sign the informed consent

Exclusion Criteria:

• Patients under 18 years of age.
• Patients with other types of thyroid cancer or whose histopathological diagnosis has not been confirmed.
• Patients who do not have the relevant basic information to be included in the study, according to the criteria of the principal investigator.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hystopathological characteristics of the tumor	Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.	Baseline
Situation of the tumor at first-diagnosis	Local tumor, locoregional tumor or metastatic disease.	Baseline
Tumor-Node-Metastasis classification	Based on the AJCC (American Joint Committee on Cancer) 2018 TNM system: T for extent or size of the tumor, N for lymph nodes spread and M for metastasis.	Baseline
Tumor Stage	From I to IV, based on the interpretation of the TNM classification and depending on the hystopathological characteristics of the tumor.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient situation at the end of treatment	Results of clinical evaluation of the disease including complete response, partial response, stable disease, progression of disease or death	12 months
Number of patients with BRAF mutation	Total patients with available results on BRAF status and proportion of patients with mutated BRAF or native BRAF.	12 months
Number of patients with RET mutation	Total patients with available results on RET status and proportion of patients with mutated RET or native RET.	12 months
Number of patients with PI3K mutation	Total patients with available results on PI3K status and proportion of patients with mutated PI3K or native PI3K.	12 months
Number of patients with RAS mutation	Total patients with available results on RAS status and proportion of patients with mutated RAS or native RAS.	12 months
Number of patients with PAX8/PAR mutation	Total patients with available results on PAX8/PAR status and proportion of patients with mutated PAX8/PAR or native PAX8/PAR.	12 months
Number of patients with P53 mutation	Total patients with available results on P53 status and proportion of patients with mutated P53 or native P53.	12 months
Number of patients with PTEN mutation	Total patients with available results on PTEN status and proportion of patients with mutated PTEN or native PTEN.	12 months

Collaborators and Investigators

• Sponsor: Grupo Espanol de Tumores Neuroendocrinos
• Investigators: Study Director: Jorge Hernando Cubero, M.D., Hospital Universitari Vall d'Hebron, Barcelona; Study Chair: Jaume Capdevila, M.D., Hospital Universitari Vall d'Hebron, Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: REGETNE-Tiroides

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No