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NCT Number: NCT02534649

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

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.

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Key information

Conditions

Solid Tumor Hematologic Diseases Hematologic Neoplasms Hematological Malignancy Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de la Côte Basque, Bayonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Newly obtained biopsy and Blood samples collection

Procedure

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine ITALIANO, MD, PhD

CONTACT

[email protected]

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Bergonié

Other

Registry information

Acronym: BIP

Important dates

Study start
2015
Primary completion
2028
Study completion
2029
First posted
Aug 28, 2015
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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