GETNE Registration of Thyroid Cancer

August 2, 2022 updated by: Grupo Espanol de Tumores Neuroendocrinos

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

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

      • Barcelona, Spain
        • Recruiting
        • Hospital Universitari Vall d'Hebrón
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hystopathological characteristics of the tumor
Time Frame: Baseline
Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.
Baseline
Situation of the tumor at first-diagnosis
Time Frame: Baseline
Local tumor, locoregional tumor or metastatic disease.
Baseline
Tumor-Node-Metastasis classification
Time Frame: 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.
Baseline
Tumor Stage
Time Frame: Baseline
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
Total patients with available results on PTEN status and proportion of patients with mutated PTEN or native PTEN.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 28, 2019

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

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)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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