GETNE Registration of Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03765333
• Other study ID #: REGETNE-Tiroides
• Status: Recruiting
• Start date: May 28, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Grupo Espanol de Tumores Neuroendocrinos
• Contact: Secretaria Técnica GETNE
• Phone: +34 93 434 44 12
• Email: getne[@]mfar.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Espanol de Tumores Neuroendocrinos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hystopathological characteristics of the tumor	Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.	Baseline
Primary	Situation of the tumor at first-diagnosis	Local tumor, locoregional tumor or metastatic disease.	Baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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