Evaluation in Real World of Molecular Testing and Treatment Patterns for EGFR Mutation in Lung Cancer Patients
PANORAMRETRO
1 other identifier
observational
463
4 countries
10
Brief Summary
Evaluate molecular testing and treatment patterns for EGFR mutation in two different cohorts of stage IV NSCLC, at diagnosis (treatment naïve) and at the moment of progression to EGFR-TKIs. This study is non-indication seeking (NIS), descriptive in nature and does not attempt to test any specific a priori hypotheses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Shorter than P25 for all trials
10 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
First Submitted
Initial submission to the registry
October 2, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedStudy Start
First participant enrolled
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2019
CompletedJune 12, 2019
June 1, 2019
3 months
October 2, 2018
June 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the EGFR mutation
Test used to determine EGFRm, registered in clinical charts
Clinical charts from January 2013-december 2017
Study Arms (2)
Cohort 1
All registered cases of stage IV NSCLC patients, treatment naïve, diagnosed in the participant institution during one year (from Jan 1st 2017 to Dec 31st 2017).
Cohort 2
All EGFR positive patients progressed to an EFGR-TKI in the same period of time (from Jan 1st 2017 to Dec 31st 2017)
Eligibility Criteria
Cohort 1: all registered cases of stage IV NSCLC patients, treatment naïve, diagnosed in the participant institution during one year (from Jan 1st 2017 to Dec 31st 2017). Cohort 2: all EGFR positive patients progressed to an EFGR-TKI in the same period of time (from Jan 1st 2017 to Dec 31st 2017) In the case one patient meets eligibility criteria for both cohorts, this patient will be included only in the EFGR-TKI progressed cohort.
You may qualify if:
- Adult male or female patients ≥ 18 years of age
- Newly diagnosed patients with stage IV NSCLC who are treatment naïve, from 1st Jan 2017 to Dec 31st 2017
- For patients still avile, provision of written informed consent as per local regulations
- Cohort 2
- Adult male or female patients ≥ 18 years of age
- Patinets Stage IV NSCLC progressed after a first line TKI from 1st Jan 2017 to Dec 31st 2017.
- For patients still avile, provision of written informed consent as per local regulations
- In the case one patient meets eligibility criteria for both cohorts, this patient will be included only in the EFGR-TKI progressed cohort.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
Research Site
CABA, Argentina
Research Site
Córdoba, Argentina
Research Site
La Plata, Argentina
Research Site
Rosario, Argentina
Research Site
Santiago, Chile
Research Site
Bogotá, Colombia
Research Site
Cali, Colombia
Research Site
Medellín, Colombia
Research Site
Montería, Colombia
Research Site
Montevideo, Uruguay
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florencia Reinhold, MD
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2018
First Posted
October 26, 2018
Study Start
November 29, 2018
Primary Completion
March 9, 2019
Study Completion
March 9, 2019
Last Updated
June 12, 2019
Record last verified: 2019-06