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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Solid Tumor Hematological Malignancy Procedure: Newly obtained biopsy and Blood samples collection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental
Newly obtained biopsy and Blood samples collection
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. - 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

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Antoine ITALIANO, MD, PhD a.italiano@bordeaux.unicancer.fr
Contact: Simone MATHOULIN-PELISSIER, MD, PhD s.mathoulin@bordeaux.unicancer.fr

Locations
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France
Centre Hospitalier de la Côte Basque Recruiting
Bayonne, France, 64000
Contact: Thomas GRELLETY, MD         
Clinique Tivoli-Ducos Recruiting
Bordeaux, France, 33000
Contact: Delphine GARBAY, MD         
Contact       d.garbay@tivoli-oncologie.fr   
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Antoine ITALIANO, MD, PhD         
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33077
Contact: Camille MAZZA, MD         
Centre Hospitalier de Pau Not yet recruiting
Pau, France, 64000
Contact: Patrick ALDO RENAULT         
Clinique Marzet Recruiting
Pau, France, 64000
Contact: Sylvestre LE MOULEC         
Centre Eugène Marquis Active, not recruiting
Rennes, France
Sponsors and Collaborators
Institut Bergonié
Investigators
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Study Chair: Antoine ITALIANO, MD, PhD Institut Bergonié
More Information
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Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT02534649    
Other Study ID Numbers: IB2015-09
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Keywords provided by Institut Bergonié:
Molecular profiling
Genomic alteration
Advanced cancer
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases