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

August 1, 2023 updated by: Latin American Cooperative Oncology Group
Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01525-001
        • A.C Camargo Cancer Center
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Centro Regional Integrado de Oncologia (CRIO)
    • RJ
      • Rio De Janeiro, RJ, Brazil
        • Instituto D'OR
    • RS
      • Porto Alegre, RS, Brazil
        • CPO Pucrs
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra O Cancer

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

Sampling Method

Non-Probability Sample

Study Population

Diagnostic patients with NSCLC and ALK rearrangement between January 2015 and December 2020.

Description

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

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
Time Frame
- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.
Time Frame: December of 2020
December of 2020
- Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.
Time Frame: December of 2020
December of 2020

Secondary Outcome Measures

Outcome Measure
Time Frame
- Estimate the progression-free survival of first-line treatment, and other subsequent lines;
Time Frame: December of 2020
December of 2020

Other Outcome Measures

Outcome Measure
Time Frame
- Estimate the overall survival from diagnosis
Time Frame: December of 2020
December of 2020
- Compare patients' outcomes among baseline characteristics defined subgroups;
Time Frame: December of 2020
December of 2020
- Evaluate health economics parameters in the context.
Time Frame: December of 2020
December of 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Latin American Cooperative Oncology Group

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)

April 6, 2020

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LACOG 1918

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.

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