Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04860076
Status:
UNKNOWN
Last Update Posted:
2021-04-26
First Post:
2021-04-23
Brief Title:
Open-label Uncontrolled Non-Interventional Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors Anti-PD-1Anti-PD-L1 Monoclonal Antibodies Treatment for Solid Tumors
Sponsor:
Asylia Diagnostics BV
Organization:
Asylia Diagnostics BV
Study Overview
Official Title:
Open-label Uncontrolled Non-Interventional Retrospective Study to Evaluate Molecular Determinants of Outcome to the Immune Checkpoint Inhibitors Anti-PD-1Anti-PD-L1 Monoclonal Antibodies Treatment for Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The recent approval of ICB treatments targeting cytotoxic T-lymphocyte antigen 4 CTLA-4 and programmed cell death-1 PD-1PD-L1 by the US Food and Drug Administration has offered an improved treatment chance for a variety of malignant tumors including those with a particularly poor prognosis However a growing number of studies and case reports show that immunotherapy may accelerate tumor progression in a significant subset of patients ranging from 9 to 27 across multiple histologies and lead to so-called hyperprogressive disease HPD that leads to a rapid patient death
During this NIS study Asylia Diagnostics aims to fill in the first layer of knowledge leading to the identification of predictive biomarkers and biological mechanisms that could be used for the prediction diagnosis and treatment of melanoma and NSCLC HPD patients
The study is a retrospective clinical study During this study basic historical medical information and scrolls from FFPE-preserved biopsies taken prior to immunotherapy treatment will be collected The nature of the study is not invasive and non interruptive to the standard of care
During this NIS study Asylia Diagnostics aims to fill in the first layer of knowledge leading to the identification of predictive biomarkers and biological mechanisms that could be used for the prediction diagnosis and treatment of melanoma and NSCLC HPD patients
The study is a retrospective clinical study During this study basic historical medical information and scrolls from FFPE-preserved biopsies taken prior to immunotherapy treatment will be collected The nature of the study is not invasive and non interruptive to the standard of care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None