Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation
NCT ID: NCT03265496
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
21 participants
INTERVENTIONAL
2016-07-07
2021-04-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recent improvement have been done in detection and characterization of blood circulating tumoral DNA (ctDNA). ctDNA reach regularly the blood stream after tumoral cell apoptosis or necrosis and could be extract and sequenced by some molecular biology technics such as real time PCR (rtPCR), digital PCR (dPCR) or next generation sequencing (NGS). Interesting, Several studies demonstrate that some genomic alterations of solid cancer can be characterized after sequencing of ctDNA. Other experiments pointed that ctDNA level could be linked to tumor stage and patient prognostic.
These progress lead to the development of a new non invasive method for extraction of ctDNA called liquid biopsy (LB). LB could be useful for monitor tumoral genotype, assess tumor response to treatment and detect residual tumor cells after curative treatment. Moreover LB could be an essential method for study of tumor cells molecular alterations mechanisms during targeted cancer therapies, when clinical resistance occurs.
Non-small cell lung cancer (NSCLC) is the most frequently diagnosticated type of lung cancer. Regular first line chemotherapy is based on the use of platinum salts. However, some mutations in the EGFR gene could add sensitivity of NSCLC to tyrosine kinase inhibitors such as gefitinib, erlotinib or afatinib. Consequently, the search for molecular mutations in genome of NSCLC cells is of prior interest for patients with clinically advanced NSCLC.
Recently, some studies demonstrate that mutational EGFR status of NSCLC was sharply correlated between tumoral tissue, obtained by classical biopsy, and ctDNA, collected by liquid biopsy.
These results provide promising data encouraging the use of LB for study of NSCLC ctDNA. However some experimentations are needed to ensure these data.
For that reason, CONCORDE clinical trial will evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. EGFR status will be assessed by real time PCR (rtPCR), digital PCR (dPCR) and Next Generation Sequencing (NGS) in patients with chemotherapy naive lung carcinoma.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
study procedure
Clinical exam. Liquid biopsy. Diagnostic exam (biopsy and imagery). 1st line treatment. tumor evaluation. Biopsy
Clinical exam
Clinical exam is performed before treatment start
Liquid biopsy
Liquid biopsy will be performed at baseline and every 3 cycles of chemotherapy until progression disease
Diagnostic exam
Diagnostic exam (biopsy and imagery exam) will be performed at baseline if not previously done or incompletely done.
1st line treatment
1st line chemotherapy (chemotherapy or EGFR targeted therapy) will be performed until progression disease.
tumor evaluation
Tumor evaluation will be performed every 3 cycles of chemotherapy
Biopsy
Biopsy will be performed at the end of study, after progression disease, if a mutation of EGFR is detected in tumor DNA.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical exam
Clinical exam is performed before treatment start
Liquid biopsy
Liquid biopsy will be performed at baseline and every 3 cycles of chemotherapy until progression disease
Diagnostic exam
Diagnostic exam (biopsy and imagery exam) will be performed at baseline if not previously done or incompletely done.
1st line treatment
1st line chemotherapy (chemotherapy or EGFR targeted therapy) will be performed until progression disease.
tumor evaluation
Tumor evaluation will be performed every 3 cycles of chemotherapy
Biopsy
Biopsy will be performed at the end of study, after progression disease, if a mutation of EGFR is detected in tumor DNA.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Metastatic lung carcinoma
* With: - EGFR gene mutation
* Or at least 2 predictive factors of addictive mutation (Women, non smocking or cessation \> 3 years, Asiatic, lung adenocarcinoma)
* Eligible for 1st line treatment
* Performance status ≤ 3
* Available tumor sample or tumor reachable for biopsy
* With informed and signed consent
* Affiliation to the National Social Security System
Exclusion Criteria
* Pregnant or breastfeeding women
* Patient not able to give consent or unwilling to provide consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Lille
OTHER
Centre Oscar Lambret
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kotecki Nuria, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Cortot Alexis, Pr
Role: PRINCIPAL_INVESTIGATOR
CHRU LILLE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Oscar Lambret
Lille, , France
CHRU Lille
Lille, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CONCORDE-1510
Identifier Type: -
Identifier Source: org_study_id