Clinical trial NCT02534649: Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Official title: Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Hematological Malignancy
Keywords: Molecular profiling
Genomic alteration
Advanced cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients presenting at least one genomic alteration
timeFrame: 1 month
Secondary outcomes:
measure: - Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)
timeFrame: Utilization rates of molecular profiling information will be evaluated until the date of death from any cause, assessed up to 36 months
measure: Rate of molecular screening failure
timeFrame: Molecular screening failure will be assessed at 1 month
measure: Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.
timeFrame: Safety will be assessed 1 month after biopsy
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Bordeaux
country: France
facility: Institut Bergonie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Pau
country: France
facility: Clinique Marzet
city: Rennes
country: France
facility: Centre Eugène Marquis
Study officials:
affiliation: Institut Bergonié
name: Antoine ITALIANO, MD, PhD
role: STUDY_CHAIR
References: