Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
BIP
1 other identifier
interventional
10,000
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
August 28, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
October 2, 2025
October 1, 2025
12.3 years
August 24, 2015
October 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients presenting at least one genomic alteration
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).
1 month
Secondary Outcomes (3)
- 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
Rate of molecular screening failure
Molecular screening failure will be assessed at 1 month
Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.
Safety will be assessed 1 month after biopsy
Study Arms (1)
Experimental
OTHERNewly obtained biopsy and Blood samples collection
Interventions
For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Four blood samples will be obtained for genetic profiling and assessment of markers The results of each tumor profile will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient. Patients for whom no molecular aberration has been identified will be treated at the discretion of the investigator and followed until death or study termination whichever occurs first. All the patients carrying a molecular aberration will be proposed to enter in a clinical trial depending on the possibility of inclusion at the time of molecular report.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years,
- Histology: solid malignant tumor or hematological malignancy,
- Deleted MSA9
- Deleted MSA9,
- Deleted MSA9,
- Deleted MSA9,
- 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.
You may not qualify if:
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Individuals deprived of liberty or placed under guardianship
- Pregnant or breast feeding women,
- Previous enrolment in the present study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Centre Hospitalier de la Côte Basque
Bayonne, 64000, France
Clinique Tivoli-Ducos
Bordeaux, 33000, France
Institut Bergonie
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077, France
Centre Hospitalier de Pau
Pau, 64000, France
Clinique Marzet
Pau, 64000, France
Centre Eugène Marquis
Rennes, France
Related Publications (1)
Guegan JP, Peyraud F, Dadone-Montaudie B, Teyssonneau D, Palmieri LJ, Clot E, Cousin S, Roubaud G, Cabart M, Leroy L, Lebreton C, Rey C, Lara O, Odin O, Brunet M, Vanhersecke L, Gruyters EO, Achour I, Belcaid L, Le Moulec S, Grellety T, Bessede A, Italiano A. Analysis of PD1, LAG3, TIGIT, and TIM3 expression in human lung adenocarcinoma reveals a 25-gene signature predicting immunotherapy response. Cell Rep Med. 2024 Dec 17;5(12):101831. doi: 10.1016/j.xcrm.2024.101831. Epub 2024 Nov 25.
PMID: 39591972DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Antoine ITALIANO, MD, PhD
Institut Bergonié
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2015
First Posted
August 28, 2015
Study Start
December 1, 2015
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
October 2, 2025
Record last verified: 2025-10