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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 : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Tracking Information
First Submitted Date  ICMJE August 24, 2015
First Posted Date  ICMJE August 28, 2015
Last Update Posted Date March 1, 2023
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date March 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • - 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Official Title  ICMJE Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Brief Summary

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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Solid Tumor
  • Hematological Malignancy
Intervention  ICMJE Procedure: Newly obtained biopsy and Blood samples collection

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.
Study Arms  ICMJE Experimental
Newly obtained biopsy and Blood samples collection
Intervention: Procedure: Newly obtained biopsy and Blood samples collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2022)		 10000
Original Estimated Enrollment  ICMJE
 (submitted: August 25, 2015)		 2000
Estimated Study Completion Date  ICMJE December 2029
Estimated Primary Completion Date March 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years,
  2. Histology: solid malignant tumor or hematological malignancy,
  3. Deleted MSA9
  4. Deleted MSA9,
  5. Deleted MSA9,
  6. Deleted MSA9,
  7. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),
  8. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

  1. Deleted MSA9
  2. Deleted MSA9
  3. Deleted MSA9
  4. Deleted MSA9
  5. Deleted MSA9
  6. Deleted MSA9
  7. Deleted MSA9
  8. Deleted MSA9
  9. Individuals deprived of liberty or placed under guardianship
  10. Pregnant or breast feeding women,
  11. Previous enrolment in the present study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD, PhD s.mathoulin@bordeaux.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02534649
Other Study ID Numbers  ICMJE IB2015-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Institut Bergonié
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Institut Bergonié
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Antoine ITALIANO, MD, PhD Institut Bergonié
PRS Account Institut Bergonié
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP