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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00685-36 | Other Identifier | ANSM IDRCB Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.
This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).
Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | For all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing. As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR gene mutation analysis on liquid biopsy | Diagnostic Test | Blood samples will be collected at inclusion for plasma DNA collection and analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis | Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure | within 3 weeks after signature of informed consent |
| Measure | Description | Time Frame |
|---|---|---|
| The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only | A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by the liquid biopsy analysis if an EGFR actionable alteration is identified based on the liquid biopsy analysis | within 3 weeks after signature of informed consent |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de l'Ouest - Site Paul Papin | Angers | 49000 | France | |||
| Institut Bergonie |
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This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation
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| The detection rate of patients with an EGFR actionable alteration based on tissue analysis only | A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by tissue analysis if an EGFR actionable alteration is identified based on the sequencing of tumor tissue | within 3 weeks after signature of informed consent |
| The concordance and discordance rates between the two procedures | Concordance is defined whenever results of both techniques are identical (i.e. EGFR+ for both techniques or EGFR- for both techniques). Discordance is defined whenever results of both techniques are different. | within 3 weeks after signature of informed consent |
| The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure) | • Failure of a procedure (sequencing of tumor tissue or liquid biopsy) is defined whenever the procedure fails to provide an interpretable result (Reasons for failure will be collected, i.e. insufficient DNA quantity, poor DNA quality, insufficient DNA/tissue quantity, poor DNA/tissue quality, analytical failure) | within 3 weeks after signature of informed consent |
| Delay to obtain sequencing results | The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure | within 3 weeks after signature of informed consent |
| Delay for treatment initiation | The delay between the date of sample collection and the date of treatment initiation | within 3 months after signature of informed consent |
| Bordeaux |
| 33076 |
| France |
| CHRU Lille | Lille | 59037 | France |
| Hospices Civils de Lyon | Lyon | 69002 | France |
| CHU Nice-Hopital de Cimiel | Nice | 06000 | France |
| Institut Curie | Paris | 75248 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| CHU de Rennes - Hopital Pontchaillou | Rennes | 35033 | France |
| CHU Strasbourg | Strasbourg | 67091 | France |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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