Skip to main content
OpenTrials
Completed

NCT Number: NCT04947683

Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil

Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Regional Integrado de Oncologia (CRIO), Fortaleza, Ceará, Brazil

Loading trial locations.

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;
  • Newly diagnosed advanced stage IIIB-IV NSCLC (AJCC 8th edition) or locally advance/distant relapse in the period of January 2015 to December 2020.
  • NSCLC with pathological confirmation of ALK rearrangement by immunohistochemistry, fluorescent in situ hybridization (FISH) or next generation sequencing (NGS);
  • ECOG 0-4;
  • Patients with CNS metastases are also considered eligible, regardless of the initial treatment instituted.

Exclusion criteria

  • Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes

Treatment and study plan

Primary outcomes

  1. - Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.

    Time frame: December of 2020

  2. - Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.

    Time frame: December of 2020

Secondary outcomes

  1. - Estimate the progression-free survival of first-line treatment, and other subsequent lines;

    Time frame: December of 2020

Other outcomes

  1. - Estimate the overall survival from diagnosis

    Time frame: December of 2020

  2. - Compare patients' outcomes among baseline characteristics defined subgroups;

    Time frame: December of 2020

  3. - Evaluate health economics parameters in the context.

    Time frame: December of 2020

Sponsors and collaborators

Lead sponsor

Latin American Cooperative Oncology Group

Other

Registry information

Acronym: ALK

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2021
Registry last updated
Aug 2, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.