Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials (BIP)
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|ClinicalTrials.gov Identifier: NCT02534649|
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : February 16, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Hematological Malignancy||Procedure: Newly obtained biopsy and Blood samples collection||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||10000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||March 2028|
|Estimated Study Completion Date :||December 2029|
Newly obtained biopsy and Blood samples collection
Procedure: Newly obtained biopsy and Blood samples collection
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.
- Proportion of patients presenting at least one genomic alteration [ Time Frame: 1 month ]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).
- - Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies) [ Time Frame: Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months ]
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
- Rate of molecular screening failure [ Time Frame: Molecular screening failure will be assessed at 1 month ]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.
- Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0. [ Time Frame: Safety will be assessed 1 month after biopsy ]Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534649
|Contact: Antoine ITALIANO, MD, PhDfirstname.lastname@example.org|
|Contact: Simone MATHOULIN-PELISSIER, MD, PhDemail@example.com|
|Centre Hospitalier de la Côte Basque||Recruiting|
|Bayonne, France, 64000|
|Contact: Thomas GRELLETY, MD|
|Clinique Tivoli-Ducos||Not yet recruiting|
|Bordeaux, France, 33000|
|Contact: Delphine GARBAY, MD|
|Bordeaux, France, 33076|
|Contact: Antoine ITALIANO, MD, PhD|
|Polyclinique Bordeaux Nord Aquitaine||Not yet recruiting|
|Bordeaux, France, 33077|
|Contact: Nadine DOHOLLOU, MD|
|Centre Hospitalier de Pau||Not yet recruiting|
|Pau, France, 64000|
|Contact: Patrick ALDO RENAULT|
|Pau, France, 64000|
|Contact: Sylvestre LE MOULEC|
|Study Chair:||Antoine ITALIANO, MD, PhD||Institut Bergonié|