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GETNE Registration of Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT03765333
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Thyroid Cancer

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Hystopathological characteristics of the tumor [ Time Frame: Baseline ]
    Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.

  2. Situation of the tumor at first-diagnosis [ Time Frame: Baseline ]
    Local tumor, locoregional tumor or metastatic disease.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765333


Contacts
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Contact: Secretaria Técnica GETNE +34 93 434 44 12 getne@mfar.net

Locations
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Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Jorge Hernando Cubero, M.D.    +34 932746085      
Principal Investigator: Jorge Hernando Cubero, M.D.         
Sponsors and Collaborators
Grupo Espanol de Tumores Neuroendocrinos
Investigators
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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
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Responsible Party: Grupo Espanol de Tumores Neuroendocrinos
ClinicalTrials.gov Identifier: NCT03765333    
Other Study ID Numbers: REGETNE-Tiroides
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms