Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02727335
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2016-03-09
Brief Title:
Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
Sponsor:
Intergroupe Francophone de Cancerologie Thoracique
Organization:
Intergroupe Francophone de Cancerologie Thoracique
Study Overview
Official Title:
Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLINALK
Brief Summary:
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib
Detailed Description:
Several French studies on crizotinib have been conducted in recent years These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU Expended Access Cohort Under the ATU program and according to ATU regulations a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes Thus it is not possible to have access to long term data and post progression data Our project is to collect data from the patients from the ATU program named patient and cohort and if possible patients treated after the marketing of crizotinib before during and after crizotinib therapy Centers selected for this observational study will be those of the IFCT network that took part in the ATU program
This will allow an accurate analysis of crizotinib therapy under real life conditions It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs
This will allow an accurate analysis of crizotinib therapy under real life conditions It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None