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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2025
  • participants needed
    2000
  • sponsor
    Institut Bergonié
Updated on 24 January 2021
cancer
hematologic malignancy
solid tumor
metastatic malignant solid tumor

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.

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.

Details
Condition Hematologic Malignancy, Blood disorder, Solid Tumors, Solid Tumor, Solid Neoplasm, Solid Tumour, Blood Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies
Treatment Newly obtained biopsy and Blood samples collection
Clinical Study IdentifierNCT02534649
SponsorInstitut Bergonié
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Histology: solid malignant tumor or hematological malignancy
Locally advanced/unresectable and/or metastatic solid tumor, refractory hematological malignancy
Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Appendix 1)
Molecular screening validated in multidisciplinary team meeting
Availability of suitable frozen or paraffin embedded archive tumor material or at least one target lesion that can be biopsied for research purpose if no frozen material is already available
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

Radiological evidence of symptomatic or progressive brain metastases
Abnormal coagulation contraindicating biopsy
Inability to swallow
Major problem with intestinal absorption
Previous allogeneic bone marrow transplant
Previous or current maligancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer
Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV)
Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
Individuals deprived of liberty or placed under guardianship
Pregnant or breast feeding women
Previous enrolment in the present study
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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