Nsclc Clinical Trial
— CONCORDEOfficial title:
Correlation Between Tissue and Plasmatic EGFR in CBNPC With EGFR Mutation or Predictive Factor of EGFR Mutation
Verified date | October 2021 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Condorde main objective is to evaluate the correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed on ctDNA 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.
Status | Terminated |
Enrollment | 21 |
Est. completion date | April 13, 2021 |
Est. primary completion date | April 13, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Oscar Lambret | Lille | |
France | CHRU Lille | Lille |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | University Hospital, Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mutation in ctDNA | To detect, at early stage, mutations on liquid biopsy. To identify, at early stage, mutations leading to treatment resistance by Next Generation Sequencing. | From Baseline to disease progression, up to 2 years | |
Other | expression pattern of tumor grade and resistance | To identify a predictive expression pattern for grade and treatment resistance of tumor by iterative sampling during treatment | From Baseline to disease progression, up to 2 years | |
Primary | Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. NGS. | 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 | Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. rtPCR. | 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 | |
Secondary | Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At diagnostic. dPCR. | 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 | |
Secondary | Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. NGS. | 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. | From Baseline to disease progression, up to 2 years | |
Secondary | Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. rtPCR. | 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 | |
Secondary | Correlation between EGFR mutational status determined after tumor biopsy and EGFR mutational status analyzed after liquid biopsy. At disease progression. dPCR. | 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 | |
Secondary | Incidence of oncogenic mutation for patients with predictive factors | To evaluate the incidence of oncogenic mutations in populations with clinical predictive factors of these mutations. | From Baseline to disease progression, up to 2 years | |
Secondary | Predictive value of ctDNA during treatment with EGFR targeting therapy. | To assess the predictive value of mutant ctDNA during treatment with EGFR targeting therapy. | From Baseline to disease progression, up to 2 years | |
Secondary | Mutations on ctDNA and tumor biopsy. | To search for mutations leading to treatment resistance on ctDNA and tumor biopsy at proved disease progression | From Baseline to disease progression, up to 2 years |
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