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Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma (PROTEOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183569
Recruitment Status : Active, not recruiting
First Posted : December 3, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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 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.

Condition or disease Intervention/treatment
Lymphoma, Large B-Cell, Diffuse Other: Sequencing RNA.

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).

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma by Transcriptomic Proteomics and Mutational Analysis
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020


Group/Cohort Intervention/treatment
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.
Other: 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




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
skin biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria
  • Patients LBC-TJ
  • Treated with R-chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183569


Locations
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France
Service de Biologie des Tumeurs et Tumorothèque
Pessac, France, 33600
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Audrey GROS, PharmD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04183569    
Other Study ID Numbers: CHUBX 2018/78
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Proteomic
Mutations
Predictive marker
Rituximab-polychemotherapy
Integrative bioinformatics tool
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin