Solid TumorBIPNCT02534649
Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
A study testing Newly obtained biopsy and Blood samples collection in people with Solid Tumor and Hematological Malignancy, run by Institut Bergonié at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Hematological Malignancy
- What is being tested?
- Newly obtained biopsy and Blood samples collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 7 sitesFrance
- Study dates
- Dec 2015to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
Show all 11Show fewer
- Deleted MSA9
- Deleted MSA9
- Individuals deprived of liberty or placed under guardianship
- Pregnant or breast feeding women,
- Previous enrolment in the present study.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Antoine ITALIANO, MD, PhD contact
Simone MATHOULIN-PELISSIER, MD, PhD contact
7 sites in 1 country
France7 sites, 6 recruiting
- Recruiting
Centre Hospitalier de la Côte Basque
Bayonne, 64000
Thomas GRELLETY, MD
- Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
Delphine GARBAY, MD
d.garbay@tivoli-oncologie.fr
- Recruiting
Institut Bergonie
Bordeaux, 33076
Antoine ITALIANO, MD, PhD
- Recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33077
Camille MAZZA, MD
- Not yet recruiting
Centre Hospitalier de Pau
Pau, 64000
Patrick ALDO RENAULT
- Recruiting
Clinique Marzet
Pau, 64000
Sylvestre LE MOULEC
- Active, not recruiting
Centre Eugène Marquis
Rennes
About this study
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.
Read the 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.
- Conditions
- Solid Tumor, Hematological Malignancy
- Being tested
- Newly obtained biopsy and Blood samples collection
- Keywords
- Molecular profiling, Genomic alteration, Advanced cancer
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newly obtained biopsy and Blood samples collectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Other | Newly obtained biopsy and Blood samples collection Receives: Procedure: Newly obtained biopsy and Blood samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (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
Measured: 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
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.
Measured: Molecular screening failure will be assessed at 1 month
Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.
Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.
Measured: Safety will be assessed 1 month after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine ITALIANO, MD, PhD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534649
- Sponsor's protocol ID
- IB2015-09
- Other IDs
- ID-RCB n°2015-A01649-40
- Acronym
- BIP
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2015
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39591972
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials
- ClinicalTrials.gov ID
- NCT02534649
- Acronym / sponsor ID
- BIP / IB2015-09
- Conditions
- Solid Tumor, Hematological Malignancy
- Keywords
- Molecular profiling, Genomic alteration, Advanced cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Other | Procedure: Newly obtained biopsy and Blood samples collectionNewly obtained biopsy and Blood samples collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years,
- Histology: solid malignant tumor or hematological malignancy,
- Deleted MSA9
- Deleted MSA9,
- Deleted MSA9,
Key exclusion criteria (11 listed)
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
- Deleted MSA9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Newly obtained biopsy and Blood samples collectionFor 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. | Procedure or surgery | Experimental |
Primary outcome
Proportion of patients presenting at least one genomic alteration
Time frame: 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).
3 secondary outcomes
- Utilization rates of molecular profiling information (including utilization of information for standard regimens or clinical trials of molecularly targeted therapies)
Time frame: 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
Time frame: Molecular screening failure will be assessed at 1 month
Safety of biopsies procedures (when applicable) graded according to NCI-CTC v4.0.
Time frame: Safety will be assessed 1 month after biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Derived from this study: PubMed 39591972Guegan 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.
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine ITALIANO, MD, PhD contact
Simone MATHOULIN-PELISSIER, MD, PhD contact
Antoine ITALIANO, MD, PhD study chair
Institut Bergonié
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newly obtained biopsy and Blood samples collection in people with Solid Tumor and Hematological Malignancy, run by Institut Bergonié at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine ITALIANO, MD, PhD (a.italiano@bordeaux.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients presenting at least one genomic alteration (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02534649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.