NCT03765333

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

6.5 years

First QC Date

November 20, 2018

Last Update Submit

October 2, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Hystopathological characteristics of the tumor

    Based on pathologist evaluation of biopsy including differentiated, medullar or anaplasic.

    Baseline

  • Situation of the tumor at first-diagnosis

    Local tumor, locoregional tumor or metastatic disease.

    Baseline

  • 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

  • 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 Outcomes (8)

  • Patient situation at the end of treatment

    12 months

  • Number of patients with BRAF mutation

    12 months

  • Number of patients with RET mutation

    12 months

  • Number of patients with PI3K mutation

    12 months

  • Number of patients with RAS mutation

    12 months

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Jorge Hernando Cubero, M.D.

    Hospital Universitari Vall d'Hebron, Barcelona

    STUDY DIRECTOR
  • Jaume Capdevila, M.D.

    Hospital Universitari Vall d'Hebron, Barcelona

    STUDY CHAIR

Central Study Contacts

Secretaria Técnica GETNE

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

December 5, 2018

Study Start

May 28, 2019

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations