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

Institut Bergonié

Status: Enrolling

Conditions: Solid Tumor; Hematological Malignancy

Treatments: Procedure: Newly obtained biopsy and Blood samples collection

Study type: Interventional

Funder types: Other

Identifiers

NCT02534649

IB2015-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years,
2. Histology: solid malignant tumor or hematological malignancy,
3. Deleted MSA9
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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
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9. Individuals deprived of liberty or placed under guardianship
10. Pregnant or breast feeding women,
11. Previous enrolment in the present study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

Experimental

Other group

Description:

Newly obtained biopsy and Blood samples collection

Treatment:

Procedure: Newly obtained biopsy and Blood samples collection