Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer (LIBIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511288
Recruitment Status : Recruiting
First Posted : July 30, 2015
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:
The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies

Condition or disease
Carcinoma, Non-Small-Cell Lung

Detailed Description:

Lung cancers are the first cause of death by cancer in the world. The majority of these patients are diagnosed at a late stage, non-eligible to a curative treatment. Due to tumoral genomic identification, it has been possible to classify NSCLC in molecular subtypes according to molecular abnormalities detection called "drivers" which can be targeted using an appropriate treatment. This change modifies the standard treatments from the very first line of treatment particularly for patients having an EGFR mutation or an ALK or ROS1 rearrangement, with a significant benefit of progression free survival. The French NCI (INCa) recommends to identify genomic alterations of a genes panel including EGFR, KRAS, BRAF, HER2, ALK and ROS1 as well as mutations in MET exon 14. However, all the patients who benefit from a targeted therapy develop resistance after a mean duration of 10-12 months after starting the treatment. In case of progression, the tumour genetic analysis through new biopsies, enables to identify these mechanisms and then to determine if the patient can benefit or not from a third generation molecule active on these mechanisms, and to have a better understanding of the disease evolution.

The detection of these alterations is routinely performed using tissular biopsies but in 10 to 20% of the cases, it is not possible.

The detection of these molecular abnormalities in the plasma, called " liquid biopsy " is a valuable non-invasive complementary approach for these patients. It is presently used in routine for detecting the EGFR mutations at diagnosis as well as for searching EGFR T790M mutation for resistant patients.

The liquid biopsies enable to detect circulating tumoral DNA.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer
Actual Study Start Date : July 2015
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort
Cohort 1
Patients with advanced NSCLC and no druggable molecular alteration at time of diagnosis
Cohort 2
Patients with advanced NSCLC harboring targetable molecular alterations at time of diagnosis
Cohort 3
Patients with advanced NSCLC at time of immunotherapy introduction (1st or 2nd line)



Primary Outcome Measures :
  1. Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA) [ Time Frame: 5 years ]
    Technique: ddPCR + targeted NGF, whole exome sequencing


Secondary Outcome Measures :
  1. Identification of genetic biomarkers (or molecular profiles) having a potential predictive value in the treatments response [ Time Frame: 5 years ]
    Techniques: ddPCR + targeted NGF, whole exome sequencing

  2. Detection of the ALK and ROS1 genes translocations in the circulating DNA [ Time Frame: 5 years ]
    Techniques: ddPCR + targeted NGF, whole exome sequencing

  3. Evaluation of the liquid biopsies role in the tumoral monitoring [ Time Frame: 5 years ]
    Correlation between mutated allelic fractions or expression's modification with the treatment response. Techniques: ddPCR + targeted NGF, whole exome sequencing

  4. Evaluation of genomic and transcriptomic factors detectable in the plasma, associated to the immunotherapy response [ Time Frame: 5 years ]
    Correlation between transcriptomic and genomic factors and response to immunotherapy. Techniques: ddPCR + targeted NGF, whole exome sequencing

  5. Evaluation of the spatial and temporal tumor heterogeneity under targeted therapy treatment [ Time Frame: 5 years ]
    Techniques: ddPCR + targeted NGF, whole exome sequencing

  6. Evaluation of the miRNAs' expression in plasma as an epigenetic factor associated to treatments response [ Time Frame: 5 years ]
    Correlation between miRNAS expression in plasma and treatment's efficacy. Techniques: miRNAs profiling using HTG technology

  7. Circulating tumoral cells isolation and analysis to determine the role of non-genomic and/or phenotypic factors in the treatments response. [ Time Frame: 5 years ]
    Single cell isolation technology

  8. Evaluation of the resistance mechanisms to targeted therapies [ Time Frame: 5 years ]
    Technique: ddPCR + targeted NGF, whole exome sequencing


Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced NSCLC
Criteria

COHORT 1

Inclusion Criteria:

  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
  • Inclusion at the time of diagnostic
  • Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  • Age ≥ 18 years
  • Covered by a health insurance
  • Signed consent

Exclusion Criteria:

- Patients treated before their liquid biopsy

COHORT 2 Inclusion criteria

  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
  • Inclusion at the time of diagnosis
  • Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  • Age ≥ 18 years
  • Covered by a health insurance
  • Signed consent

COHORT 3 Inclusion criteria

  • Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) whatever the mutational or PD-L1 status.
  • Inclusion at the time of immunotherapy treatment initiation (1st or 2nd line)
  • Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  • Age ≥ 18 years
  • Covered by a health insurance
  • Signed consent

Exclusion criteria

- Initiation of immunotherpy before their liquid biopsy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511288


Contacts
Layout table for location contacts
Contact: Pierre Saintigny, MD, PhD pierre.saintigny@lyon.unicancer.fr

Locations
Layout table for location information
France
Centre Hospitalier Annecy Genevois Recruiting
Annecy, France
Contact: Stéphane Hominal, MD    +33 4.50.63.66.03    shominal@ch-annecygenevois.fr   
CH Fleyriat Recruiting
Bourg-en-Bresse, France
Contact: Pascal Beynel, MD    +33 4.74.45.40.30    pbeynel@ch-bourg01.fr   
Hôpital Louis Pradel Recruiting
Bron, France, 69677
Contact: Marylise Ginoux, MD    +33 4.27.85.77.00    marylise.ginoux@chu-lyon.fr   
CHU Grenoble Alpes Recruiting
Grenoble, France
Contact: Denis Moro-Sibilot, MD    +33 4.76..76.87.08    smoro-sibilot@chu-grenoble.fr   
Centre Léon Bérard Recruiting
Lyon, France, 69008
Contact: Pierre Saintigny, MD-PhD    +33 478782781    pierre.saintigny@lyon.unicancer.fr   
CHRU de Saint-Etienne Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Claire TISSOT, MD    +33 4.77.82.83.14    claire.tissot@chu-st-etienne.fr   
Institut de Cancérologie Lucien Neuwirth Recruiting
Saint-Priest-en-Jarez, France, 42270
Contact: Pierre Fournel, MD    +33 4.77.91.70.36    pierre.fournel@icloire.fr   
Hôpital Nord Ouest Recruiting
Villefranche-sur-Saône, France, 69655
Contact: Luc Odier, MD    +33 4.74.09.27.23    lodier@lhopitalnordouest.fr   
Sponsors and Collaborators
Centre Leon Berard
Investigators
Layout table for investigator information
Study Director: Pierre Saintigny, MD, PhD pierre.saintigny@lyon.unicancer.fr
Layout table for additonal information
Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT02511288    
Other Study ID Numbers: ET15-076 LIBIL
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Keywords provided by Centre Leon Berard:
Hematologic test
Liquid biopsy
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases