Lymphoma, Large B-Cell, DiffusePROTEOMNCT04183569
Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma
An observational study of Lymphoma, Large B-Cell, Diffuse, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study is performed on a single-center retrospective cohort of 32 patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomas managed by Professor Beylot-Barry and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Sequencing RNA.
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2019to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomasmanaged by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier.
- Patients LBC-TJ
- Treated with R-chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma by Transcriptomic Proteomics and Mutational Analysis
The study is performed on a single-center retrospective cohort of 32 patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomas managed by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier. Fourteen patients responded to the R-PCT against 18 non-responders, 14 patients for whom we have the sample to recidivism.
Read the detailed description
The objective is to identify predictive biomarkers of response to R-chemotherapy and understand what genomic markers, transcriptomic or proteomic would identify those patients ahead. This would ultimately help to identify whether dysregulated biological pathway could be targeted specifically among patients with personalized treatment.
Like its counterpart systemic Lymphoma Diffuse large B cell, the sequential analysis of the same patient at diagnosis and relapse can also identify candidate genes and biological pathways involved in recurrence and help to design new therapeutic strategies.
Another objective is ultimately the development of an integrative bioinformatics tool for anticipating the therapeutic response. The tumor model used is certainly a rare cancer but prototypical ABC lymphomas allowing access to relapse hardware and relative homogeneity that will allow a study of a smaller number of cases for the development of correlations models genomics / proteomics. This is a pivotal project integrating proteomic data and Molecular Biology (mutation, expression) based on the pooling of skills of clinical teams, biological and bioinformatics to validate a predictive model for treatment response able to integrate prognostic markers known as TNM the dual expression MYC / BCL2 and forward to predict the therapeutic response using this modeling by CBIB. We would then validate the model established in this series of training on a range of national validation as part of an observational study with GFELC (Groupe Français d'Etude des Lymphomes Cutanés).
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- Sequencing RNA.
- Keywords
- Proteomic, Mutations, Predictive marker, Rituximab-polychemotherapy, Integrative bioinformatics tool
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequencing RNA.Other
RNA-seq, central pivot between genomics and proteomics allows to make the connection between the observed mutations and alteration of protein expression with the identification and quantification of RNA. Thus, we can attest to the expression of mutations identified on DNA, protein and understand whether deregulation is linked to dysregulation of transcription or post-translational modification
| Study group | Role | What they receive |
|---|---|---|
| Primary diffuse cutaneous B-cell lymphoma, leg type | Cohort of 32 patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomas managed by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier. Receives: Other: Sequencing RNA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe of mutations in genes
To characterize the tumours, a sequencing of dedicated lymphopanel targeting the most frequently altered genes in large B-cell lymphomas was performed. Several highly recurrent mutations of MYD88, PIM1, CD79B and MYC, as well as CDKN2A, BLIMP1 and TNFAIP3 deletions were detected per patient leading to the putative deregulation of several biological pathways. These sequencing data have evidenced the genetic diversity and complexity of PCLBCL, LT mutational landscape.
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start19 Feb 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey GROS, PharmD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183569
- Sponsor's protocol ID
- CHUBX 2018/78
- Acronym
- PROTEOM
- Status last verified
- Apr 2020
- First submitted
- 28 Nov 2019
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma by Transcriptomic Proteomics and Mutational Analysis
- ClinicalTrials.gov ID
- NCT04183569
- Acronym / sponsor ID
- PROTEOM / CHUBX 2018/78
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- Proteomic, Mutations, Predictive marker, Rituximab-polychemotherapy, Integrative bioinformatics tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 3 Dec 2019 (actual)
- 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.
The study is performed on a single-center retrospective cohort of 32 patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomas managed by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier. Fourteen patients responded to the R-PCT against 18 non-responders, 14 patients for whom we have the sample to recidivism.
Detailed description
The objective is to identify predictive biomarkers of response to R-chemotherapy and understand what genomic markers, transcriptomic or proteomic would identify those patients ahead. This would ultimately help to identify whether dysregulated biological pathway could be targeted specifically among patients with personalized treatment.
Like its counterpart systemic Lymphoma Diffuse large B cell, the sequential analysis of the same patient at diagnosis and relapse can also identify candidate genes and biological pathways involved in recurrence and help to design new therapeutic strategies.
Another objective is ultimately the development of an integrative bioinformatics tool for anticipating the therapeutic response. The tumor model used is certainly a rare cancer but prototypical ABC lymphomas allowing access to relapse hardware and relative homogeneity that will allow a study of a smaller number of cases for the development of correlations models genomics / proteomics. This is a pivotal project integrating proteomic data and Molecular Biology (mutation, expression) based on the pooling of skills of clinical teams, biological and bioinformatics to validate a predictive model for treatment response able to integrate prognostic markers known as TNM the dual expression MYC / BCL2 and forward to predict the therapeutic response using this modeling by CBIB. We would then validate the model established in this series of training on a range of national validation as part of an observational study with GFELC (Groupe Français d'Etude des Lymphomes Cutanés).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary diffuse cutaneous B-cell lymphoma, leg type | – | Other: Sequencing RNA.Cohort of 32 patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomas managed by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients LBC-TJ treated with R-chemotherapy for which data collection was carried out in homogeneous and prospectively followed according to international standards through RCP monthly cutaneous lymphomasmanaged by Professor Beylot-Barry and inclusion of cases in the national database of rare cancer network French Study Group of Cutaneous Lymphomas in Bordeaux managed by Prof. Beatrice Vergier.
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 |
|---|---|---|
| Sequencing RNA.RNA-seq, central pivot between genomics and proteomics allows to make the connection between the observed mutations and alteration of protein expression with the identification and quantification of RNA. Thus, we can attest to the expression of mutations identified on DNA, protein and understand whether deregulation is linked to dysregulation of transcription or post-translational modification | Other | Primary diffuse cutaneous B-cell lymphoma, leg type |
Primary outcome
Describe of mutations in genes
Time frame: day1
To characterize the tumours, a sequencing of dedicated lymphopanel targeting the most frequently altered genes in large B-cell lymphomas was performed. Several highly recurrent mutations of MYD88, PIM1, CD79B and MYC, as well as CDKN2A, BLIMP1 and TNFAIP3 deletions were detected per patient leading to the putative deregulation of several biological pathways. These sequencing data have evidenced the genetic diversity and complexity of PCLBCL, LT mutational landscape.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Audrey GROS, PharmD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Large B-Cell, Diffuse, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe of mutations in genes (time frame: day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.