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Recruiting

NCT Number: NCT03765333

GETNE Registration of Thyroid Cancer

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.

Recruiting

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location status: Recruiting

Location contact

A responsible person designated by the sponsor, M.D.

CONTACT

[email protected]

Principal investigator selected by the sponsor, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Secretaria Técnica GETNE

CONTACT

[email protected]

+34 93 434 44 12

Sponsors and collaborators

Lead sponsor

Grupo Espanol de Tumores Neuroendocrinos

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2018
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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