Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05122806
Status:
RECRUITING
Last Update Posted:
2023-10-19
First Post:
2021-09-06
Brief Title:
Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
Sponsor:
Groupe Francais De Pneumo-Cancerologie
Organization:
Groupe Francais De Pneumo-Cancerologie
Study Overview
Official Title:
Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung NSCLC Cancer Included in EXPLOREALK Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
BIOEXALK
Brief Summary:
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line included in the national EXPLORE ALK cohort GFPC 03-2019 a non-interventional national multi-center cohort of ALK-rearranged NSCLC patients
BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study
Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA ctDNA
For plasma testing after obtained patient consent blood samples will be taken and analyzed at the Léon Bérard Center Lyon
Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital
BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study
Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA ctDNA
For plasma testing after obtained patient consent blood samples will be taken and analyzed at the Léon Bérard Center Lyon
Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital
Detailed Description:
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with new generation TKIs in first line included in the national EXPLORE ALK cohort GFPC 03-2019
Explore ALK GFPC 03-2019 is a non-interventional national multi-center cohort of ALK-rearranged NSCLC patients whose RCB reference is 2020-A00771-38 and which obtained an approval from the IDF II Ethic Committee on 25052020 Biological analysis will be performed on tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA ctDNA on three timepoints diagnosis at first tumor evaluation and at the time of disease progression
Tissue RNAseq will be performed on tumor biopsy 10 slides of 5 microns to identify the ALK fusion partner and its variant and associated co-mutations
ctDNA NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples 30mL on EDTA or STRECKs tubes at diagnosis at the time of the first evaluation and at the time of progression
For plasma testing after obtained patient consent blood samples 35mL on EDTA or STRECKs tubes at diagnosis at the first evaluation and at disease progression will be taken
The ALKis include alectinib and brigatinib as first-line therapy or other drugs with marketing authorizations lorlatinib entrectinib or in early access programs EAPs
Liquid biopsies will be analyzed with a NGS panel allowing the identification of ALK fusion partners and resistance mechanisms mutations fusions copy number variations Samples will be sent for centralized analysis to the Léon Bérard Center Lyon
For biological analysis on tissue obtained at diagnosis the ALK fusion partner and its variant will be identified by RNAseq Whenever a tissue re-biopsy is performed at the time of disease progression as part of the standard of care management of the patient the remaining tissue sample will be collected as part of the BioExALK study so that RNAseq analysis will be performed to look for resistance mechanisms Tissue samples 10 slides of 5 microns will be sent for centralized analysis to the Rouen University Hospital
Explore ALK GFPC 03-2019 is a non-interventional national multi-center cohort of ALK-rearranged NSCLC patients whose RCB reference is 2020-A00771-38 and which obtained an approval from the IDF II Ethic Committee on 25052020 Biological analysis will be performed on tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA ctDNA on three timepoints diagnosis at first tumor evaluation and at the time of disease progression
Tissue RNAseq will be performed on tumor biopsy 10 slides of 5 microns to identify the ALK fusion partner and its variant and associated co-mutations
ctDNA NGS panel on DNA including a large panel of fusions and mutations will be performed on blood samples 30mL on EDTA or STRECKs tubes at diagnosis at the time of the first evaluation and at the time of progression
For plasma testing after obtained patient consent blood samples 35mL on EDTA or STRECKs tubes at diagnosis at the first evaluation and at disease progression will be taken
The ALKis include alectinib and brigatinib as first-line therapy or other drugs with marketing authorizations lorlatinib entrectinib or in early access programs EAPs
Liquid biopsies will be analyzed with a NGS panel allowing the identification of ALK fusion partners and resistance mechanisms mutations fusions copy number variations Samples will be sent for centralized analysis to the Léon Bérard Center Lyon
For biological analysis on tissue obtained at diagnosis the ALK fusion partner and its variant will be identified by RNAseq Whenever a tissue re-biopsy is performed at the time of disease progression as part of the standard of care management of the patient the remaining tissue sample will be collected as part of the BioExALK study so that RNAseq analysis will be performed to look for resistance mechanisms Tissue samples 10 slides of 5 microns will be sent for centralized analysis to the Rouen University Hospital
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GFPC 08-2020 | OTHER | GroupeFDPC | None |