Ignite Creation Date:
2024-05-06 @ 12:18 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03721120
Status:
COMPLETED
Last Update Posted:
2023-08-31
First Post:
2018-10-17
Brief Title:
Evaluation of the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
A Randomized Phase III Clinical Trial to Evaluate the Feasibility and Clinical Relevance of Liquid Biopsy in Patients With Suspicious Metastatic Lung Cancer
Status:
COMPLETED
Status Verified Date:
2023-08
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:
LIBELULE
Brief Summary:
Lung cancer is diagnosed at metastatic stage in 60 of the cases For these patients first-line treatment is based on histology and molecular characterization of non-squamous non-small cell lung cancer NSCLC Thus quality and quantity of tumor tissue are crucial to determine the appropriate treatment targeted therapies chemotherapy and immunotherapy
However in routine practice tissue quality and quantity can be limited 25 resulting in the need for tumor rebiopsy for molecular analysis Therefore lung cancer patients often experience substantial delays before treatment initiation that may be associated with worse patient experience of subsequent cancer care and poorer clinical outcomes
Liquid biopsies LB are used to detect genomic alterations in cell-free circulating DNA cfDNA Since very recently they are routinely used in reference centers for the detection of EGFR-mutations when tissue is not sufficient for molecular characterization Importantly the feasibility and clinical relevance of systematic liquid biopsies in routine practice has never been evaluated in patients with suspicious advanced lung cancer
Investigators hypothesize that using systematic LB in patients with clinical suspicion of metastatic lung cancer may reduce time-to-treatment initiation and avoid tissue rebiopsy
Investigators performed a retrospective study including 250 NSCLC patients treated in a tertiary Cancer Center and in the University Hospital of Lyon France The mean time-to-appropriate frontline treatment initiation TTI was 42-225 days With the use of LB at the time of first consultation the investigators believe it is possible to reduce the mean TTI down to 33 days 21 reduction in TTI in the overall population with suspicious metastatic lung cancer including a 50 and 40 reduction in TTI for EGFRALKROS1BRAF V600E subgroups and KRASLKB1ERBB2c-METBRAF non V600E subgroups respectively
Investigators therefore designed a real-life randomized study to evaluate the feasibility and clinical relevance of LB to decrease the TTI which may in turn improve patients outcome Genomic analyses of circulating cfDNA will be performed using a robust and highly sensitive technology InVision that profiles the presence of genomic aberrations in a panel of 35 genes including mutations insertiondeletions and rearrangements including all actionable alterations required to initiate the appropriate first-line therapy EGFR- ALK- ROS1 and BRAF V600E
However in routine practice tissue quality and quantity can be limited 25 resulting in the need for tumor rebiopsy for molecular analysis Therefore lung cancer patients often experience substantial delays before treatment initiation that may be associated with worse patient experience of subsequent cancer care and poorer clinical outcomes
Liquid biopsies LB are used to detect genomic alterations in cell-free circulating DNA cfDNA Since very recently they are routinely used in reference centers for the detection of EGFR-mutations when tissue is not sufficient for molecular characterization Importantly the feasibility and clinical relevance of systematic liquid biopsies in routine practice has never been evaluated in patients with suspicious advanced lung cancer
Investigators hypothesize that using systematic LB in patients with clinical suspicion of metastatic lung cancer may reduce time-to-treatment initiation and avoid tissue rebiopsy
Investigators performed a retrospective study including 250 NSCLC patients treated in a tertiary Cancer Center and in the University Hospital of Lyon France The mean time-to-appropriate frontline treatment initiation TTI was 42-225 days With the use of LB at the time of first consultation the investigators believe it is possible to reduce the mean TTI down to 33 days 21 reduction in TTI in the overall population with suspicious metastatic lung cancer including a 50 and 40 reduction in TTI for EGFRALKROS1BRAF V600E subgroups and KRASLKB1ERBB2c-METBRAF non V600E subgroups respectively
Investigators therefore designed a real-life randomized study to evaluate the feasibility and clinical relevance of LB to decrease the TTI which may in turn improve patients outcome Genomic analyses of circulating cfDNA will be performed using a robust and highly sensitive technology InVision that profiles the presence of genomic aberrations in a panel of 35 genes including mutations insertiondeletions and rearrangements including all actionable alterations required to initiate the appropriate first-line therapy EGFR- ALK- ROS1 and BRAF V600E
Detailed Description:
None
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