BIP: Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

Sponsor
Institut Bergonié (Other)
Overall Status
Recruiting
CT.gov ID
NCT02534649
Collaborator
(none)
10,000
6
1
168
1666.7
9.9

Study Details

Study Description

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
  • Procedure: Newly obtained biopsy and Blood samples collection
N/A

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

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2028
Anticipated Study Completion Date :
Dec 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Proportion of patients presenting at least one genomic alteration [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) [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 [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. [Safety will be assessed 1 month after biopsy]

    Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Centre Hospitalier de la Côte Basque Bayonne France 64000
2 Clinique Tivoli-Ducos Bordeaux France 33000
3 Institut Bergonie Bordeaux France 33076
4 Polyclinique Bordeaux Nord Aquitaine Bordeaux France 33077
5 Centre Hospitalier de Pau Pau France 64000
6 Clinique Marzet Pau France 64000

Sponsors and Collaborators

  • Institut Bergonié

Investigators

  • Study Chair: Antoine ITALIANO, MD, PhD, Institut Bergonié

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT02534649
Other Study ID Numbers:
  • IB2015-09
First Posted:
Aug 28, 2015
Last Update Posted:
Feb 16, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Institut Bergonié
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022