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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10,000
For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Four blood samples will be obtained for genetic profiling and assessment of markers The results of each tumor profile will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision 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.
Centre Hospitalier de la Côte Basque
Bayonne, France
RECRUITINGClinique Tivoli-Ducos
Bordeaux, France
RECRUITINGInstitut Bergonie
Bordeaux, France
RECRUITINGPolyclinique Bordeaux Nord Aquitaine
Bordeaux, France
RECRUITINGCentre Hospitalier de Pau
Pau, France
NOT_YET_RECRUITINGClinique Marzet
Pau, France
RECRUITINGCentre Eugène Marquis
Rennes, France
ACTIVE_NOT_RECRUITINGProportion 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).
Time frame: 1 month
- 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 : * Inclusion in a clinical trial assessing a drug matched with the genetic profile * Treatment with an approved drug matched with the genetic profile
Time frame: 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.
Time frame: 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.
Time frame: Safety will be assessed 1 month after biopsy
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