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

Not Applicable

Recruiting

• Conditions: Hematological Malignancy; Solid Tumor
• Interventions: Procedure: Newly obtained biopsy and Blood samples collection

• Registration Number: 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.

Study Timeline

• Study First Submitted: 2015-08-24
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-28
• Study Start: 2015-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01
• Primary Completion: 2028-03
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. Age ≥ 18 years,
2. Histology: solid malignant tumor or hematological malignancy,
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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

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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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Newly obtained biopsy and Blood samples collection	Newly obtained biopsy and Blood samples collection

Primary Outcome Measures

Name	Time	Method
Proportion of patients presenting at least one genomic alteration	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 Outcome Measures

Name	Time	Method
- Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)	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
Rate of molecular screening failure	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.
Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.	Safety will be assessed 1 month after biopsy	Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.

Trial Locations

Locations (7)

Clinique Tivoli-Ducos; 🇫🇷 Bordeaux, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Hospitalier de Pau; 🇫🇷 Pau, France

Clinique Marzet; 🇫🇷 Pau, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France