GETNE Registration of Thyroid Cancer

Recruiting

• Conditions: Thyroid Cancer

• Registration Number: NCT03765333
• Lead Sponsor: Grupo Espanol de Tumores Neuroendocrinos

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-05
• Study Start: 2019-05-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Situation of the tumor at first-diagnosis	Baseline	Local tumor, locoregional tumor or metastatic disease.
Tumor-Node-Metastasis classification	Baseline	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.
Tumor Stage	Baseline	From I to IV, based on the interpretation of the TNM classification and depending on the hystopathological characteristics of the tumor.
Hystopathological characteristics of the tumor	Baseline	Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain