- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02534649
Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials (BIP)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bayonne, France, 64000
- Recruiting
- Centre Hospitalier de la Cote Basque
-
Bordeaux, France, 33076
- Recruiting
- Institut Bergonié
-
Contact:
- Antoine Italiano, MD, PhD
-
Bordeaux, France, 33000
- Recruiting
- Clinique Tivoli-Ducos
-
Contact:
- Delphine GARBAY, MD
-
Contact:
- Email: d.garbay@tivoli-oncologie.fr
-
Bordeaux, France, 33077
- Recruiting
- Polyclinique Bordeaux Nord Aquitaine
-
Contact:
- Camille MAZZA, MD
-
Pau, France, 64000
- Not yet recruiting
- Centre Hospitalier de Pau
-
Contact:
- Patrick ALDO RENAULT
-
Pau, France, 64000
- Recruiting
- Clinique Marzet
-
Contact:
- Sylvestre LE MOULEC
-
Rennes, France
- Active, not recruiting
- Centre Eugene Marquis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 18 years,
- Histology: solid malignant tumor or hematological malignancy,
- Deleted MSA9
- Deleted MSA9,
- Deleted MSA9,
- Deleted MSA9,
- Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),
- Voluntary signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria:
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Individuals deprived of liberty or placed under guardianship
- Pregnant or breast feeding women,
- Previous enrolment in the present study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Experimental
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- 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 :
|
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
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.
|
Molecular screening failure will be assessed at 1 month
|
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.
|
Safety will be assessed 1 month after biopsy
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Antoine ITALIANO, MD, PhD, Institut Bergonié
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IB2015-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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