Patient Journey With Advanced Lung Cancer Positive for ALK Fusion in Brazil
ALK
1 other identifier
observational
101
1 country
5
Brief Summary
Observational, retrospective cohort study that will include patients diagnosed with NSCLC and ALK rearrangement between January 2015 and December 2020.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Typical duration for all trials
5 active sites
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
Study Start
First participant enrolled
April 6, 2020
CompletedFirst Submitted
Initial submission to the registry
June 24, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2023
CompletedAugust 2, 2023
August 1, 2023
2.9 years
June 24, 2021
August 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
- Describe the treatment sequencing of ALK positive advanced NSCLC in a real-world setting.
December of 2020
- Describe the timelines from the appearance of symptoms, histopathological diagnosis, application of the molecular test, and start of treatment.
December of 2020
Secondary Outcomes (1)
- Estimate the progression-free survival of first-line treatment, and other subsequent lines;
December of 2020
Other Outcomes (3)
- Estimate the overall survival from diagnosis
December of 2020
- Compare patients' outcomes among baseline characteristics defined subgroups;
December of 2020
- Evaluate health economics parameters in the context.
December of 2020
Eligibility Criteria
Diagnostic patients with NSCLC and ALK rearrangement between January 2015 and December 2020.
You may qualify if:
- 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.
You may not qualify if:
- \- Incomplete medical chart in terms of date of diagnosis, ALK test results and outcomes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Centro Regional Integrado de Oncologia (CRIO)
Fortaleza, Ceará, Brazil
Instituto D'OR
Rio de Janeiro, Rio de Janeiro, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, 59075-740, Brazil
CPO Pucrs
Porto Alegre, Rio Grande do Sul, Brazil
A.C Camargo Cancer Center
São Paulo, 01525-001, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2021
First Posted
July 1, 2021
Study Start
April 6, 2020
Primary Completion
February 14, 2023
Study Completion
March 3, 2023
Last Updated
August 2, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share