Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Bergonié
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years,
Histology: solid malignant tumor or hematological malignancy,
Deleted MSA9
Deleted MSA9,
Disqualifiers
Deleted MSA9
Deleted MSA9
Deleted MSA9
Deleted MSA9
Trial design
Design model
Single group
Treatments tested in this trial
Newly obtained biopsy and Blood samples collection
Procedure/SurgeryFor 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.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: ExperimentalOther 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
1 monthSecondary outcomes
1
- 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 months2
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 month3
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 biopsySponsors and contacts
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Source ClinicalTrials.gov