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This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.
In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.
Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.
The need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. This "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment.
The main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. This study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. Such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Other | Newly obtained biopsy and Blood samples collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Newly obtained biopsy and Blood samples collection | Procedure | For each patient:
Patients for whom no molecular aberration has been identified will be treated at the discretion of the investigator and followed until death or study termination whichever occurs first. All the patients carrying a molecular aberration will be proposed to enter in a clinical trial depending on the possibility of inclusion at the time of molecular report. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients presenting at least one genomic alteration | The proportion of patients with advanced cancer presenting at least one genomic alteration will be described in the NGS population and reported using the proportion. The 95% two-sided confidence limits (95%CI) will be provided for the calculated rate (binomial law). | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| - Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) | Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies. For a patient with NGS results available, utilization of molecular profiling information is defined as :
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine ITALIANO, MD, PhD | Contact | a.italiano@bordeaux.unicancer.fr | ||
| Simone MATHOULIN-PELISSIER, MD, PhD | Contact | s.mathoulin@bordeaux.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine ITALIANO, MD, PhD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de la CĂ´te Basque | Recruiting | Bayonne | 64000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39591972 | Derived | Guegan JP, Peyraud F, Dadone-Montaudie B, Teyssonneau D, Palmieri LJ, Clot E, Cousin S, Roubaud G, Cabart M, Leroy L, Lebreton C, Rey C, Lara O, Odin O, Brunet M, Vanhersecke L, Gruyters EO, Achour I, Belcaid L, Le Moulec S, Grellety T, Bessede A, Italiano A. Analysis of PD1, LAG3, TIGIT, and TIM3 expression in human lung adenocarcinoma reveals a 25-gene signature predicting immunotherapy response. Cell Rep Med. 2024 Dec 17;5(12):101831. doi: 10.1016/j.xcrm.2024.101831. Epub 2024 Nov 25. |
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| Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months |
| Rate of molecular screening failure | Rate of molecular screening failure. Molecular screening failure is defined as the impossibility to provide genetic profiling because as a result of inadequate tissue or DNA quantity or quality. | Molecular screening failure will be assessed at 1 month |
| Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0. | Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0. | Safety will be assessed 1 month after biopsy |
| Clinique Tivoli-Ducos | Recruiting | Bordeaux | 33000 | France |
|
| Institut Bergonie | Recruiting | Bordeaux | 33076 | France |
|
| Polyclinique Bordeaux Nord Aquitaine | Recruiting | Bordeaux | 33077 | France |
|
| Centre Hospitalier de Pau | Not yet recruiting | Pau | 64000 | France |
|
| Clinique Marzet | Recruiting | Pau | 64000 | France |
|
| Centre Eugène Marquis | Active, not recruiting | Rennes | France |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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