Official Title
Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Brief Title
Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
Protocol ID
NCT02534649
Lead Sponsor
Institut Bergonié
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.
Enrollment Count
10,000 participants
Eligibility Criteria
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.
Filters
Solid Tumor
Hematological Malignancy
NA
RECRUITING
ADULT
OLDER_ADULT