- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03265496
Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation (CONCORDE)
Study Overview
Status
Conditions
Detailed Description
Newest therapeutic breakthrough are often based on molecular analysis of tumoral tissue before treatment initiation or after emergence of resistance. Tumoral tissue is commonly obtained by biopsy. However, tumor biopsy is an invasive, scarcely repeatable and costly technics. Moreover, tumor samples, obtained by biopsy, doesn't represent tumor heterogeneity and cannot inform about tumor evolution over time.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lille, France, 59020
- Centre Oscar Lambret
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Lille, France, 59037
- CHRU Lille
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years
- 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:
- Previous radiotherapy treatment in months preceding initials samples
- Pregnant or breastfeeding women
- Patient not able to give consent or unwilling to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study procedure
Clinical exam.
Liquid biopsy.
Diagnostic exam (biopsy and imagery).
1st line treatment.
tumor evaluation.
Biopsy
|
Clinical exam is performed before treatment start
Liquid biopsy will be performed at baseline and every 3 cycles of chemotherapy until progression disease
Diagnostic exam (biopsy and imagery exam) will be performed at baseline if not previously done or incompletely done.
1st line chemotherapy (chemotherapy or EGFR targeted therapy) will be performed until progression disease.
Other Names:
Tumor evaluation will be performed every 3 cycles of chemotherapy
Biopsy will be performed at the end of study, after progression disease, if a mutation of EGFR is detected in tumor DNA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. NGS.
Time Frame: Baseline
|
For patient with mutant EGFR.
Evaluate, by next generation sequencing at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. rtPCR.
Time Frame: Baseline
|
For patient with mutant EGFR.
Evaluate, by real time PCR at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.
|
Baseline
|
Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. dPCR.
Time Frame: Baseline
|
For patient with mutant EGFR.
Evaluate, by digital PCR at diagnostic, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.
|
Baseline
|
Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. NGS.
Time Frame: From Baseline to disease progression, up to 2 years
|
For patient with mutant EGFR.
Evaluate, by Next Generation Sequencing at disease progression, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.
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From Baseline to disease progression, up to 2 years
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Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. rtPCR.
Time Frame: From Baseline to disease progression, up to 2 years
|
For patient with mutant EGFR.
Evaluate, by rtPCR at disease progression, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.
|
From Baseline to disease progression, up to 2 years
|
Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. dPCR.
Time Frame: From Baseline to disease progression, up to 2 years
|
For patient with mutant EGFR.
Evaluate, by dPCR at disease progression, the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy.
|
From Baseline to disease progression, up to 2 years
|
Incidence of oncogenic mutation for patients with predictive factors
Time Frame: From Baseline to disease progression, up to 2 years
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To evaluate the incidence of oncogenic mutations in populations with clinical predictive factors of these mutations.
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From Baseline to disease progression, up to 2 years
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Predictive value of ctDNA during treatment with EGFR targeting therapy.
Time Frame: From Baseline to disease progression, up to 2 years
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To assess the predictive value of mutant ctDNA during treatment with EGFR targeting therapy.
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From Baseline to disease progression, up to 2 years
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Mutations on ctDNA and tumor biopsy.
Time Frame: From Baseline to disease progression, up to 2 years
|
To search for mutations leading to treatment resistance on ctDNA and tumor biopsy at proved disease progression
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From Baseline to disease progression, up to 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mutation in ctDNA
Time Frame: From Baseline to disease progression, up to 2 years
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To detect, at early stage, mutations on liquid biopsy.
To identify, at early stage, mutations leading to treatment resistance by Next Generation Sequencing.
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From Baseline to disease progression, up to 2 years
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expression pattern of tumor grade and resistance
Time Frame: From Baseline to disease progression, up to 2 years
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To identify a predictive expression pattern for grade and treatment resistance of tumor by iterative sampling during treatment
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From Baseline to disease progression, up to 2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kotecki Nuria, MD, Centre Oscar Lambret
- Principal Investigator: Cortot Alexis, Pr, CHRU Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CONCORDE-1510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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