- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03765333
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
-
-
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Barcelona, Spain
- Recruiting
- Hospital Universitari Vall d'Hebrón
-
Contact:
- A responsible person designated by the sponsor, M.D.
- Email: investigacion@mfar.net
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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
Additional Relevant MeSH Terms
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
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.
Clinical Trials on Thyroid Cancer
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National Cancer Institute (NCI)TerminatedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid Cancer | Anaplastic Thyroid Cancer | Stage III Follicular Thyroid Cancer | Stage III Papillary Thyroid CancerUnited States
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University of WashingtonNational Cancer Institute (NCI); GlaxoSmithKline; National Comprehensive Cancer...CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States
-
University of PennsylvaniaCompletedMetastatic Medullary Thyroid Cancer | Metastatic Differentiated Thyroid Cancer | Metastatic Anaplastic Thyroid Cancer | Metastatic Poorly Differentiated Thyroid CancerUnited States
-
National Cancer Institute (NCI)CompletedInsular Thyroid Cancer | Recurrent Thyroid Cancer | Stage II Follicular Thyroid Cancer | Stage II Papillary Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
Children's Hospital of PhiladelphiaBayerRecruitingCancer | Pediatric Cancer | Differentiated Thyroid Cancer | Cancer, ThyroidUnited States
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Massachusetts General HospitalEli Lilly and CompanyRecruitingThyroid Carcinoma | Thyroid Cancer | Papillary Thyroid Cancer | Metastatic Thyroid Cancer | Follicular Thyroid Cancer | Unresectable Thyroid Gland CarcinomaUnited States
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H. Lee Moffitt Cancer Center and Research InstituteTerminatedThyroid Cancer, Medullary | Thyroid Cancer | Papillary Thyroid Cancer | Differentiated Thyroid Cancer | Poorly Differentiated Thyroid Gland Carcinoma | Follicular Thyroid CancerUnited States
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National Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Stage IV Follicular Thyroid Cancer | Stage IV Papillary Thyroid CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedRecurrent Thyroid Cancer | Thyroid Gland Medullary Carcinoma | Stage IVA Follicular Thyroid Cancer | Stage IVA Papillary Thyroid Cancer | Stage IVB Follicular Thyroid Cancer | Stage IVB Papillary Thyroid Cancer | Stage IVC Follicular Thyroid Cancer | Stage IVC Papillary Thyroid CancerUnited States