Clinical trial NCT04183569: Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma
Official title: Identification Predictive Markers of Immunochemotherapy Response to the Primary Cutaneous Diffuse Large B Cell Lymphoma by Transcriptomic Proteomics and Mutational Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: Proteomic
Mutations
Predictive marker
Rituximab-polychemotherapy
Integrative bioinformatics tool
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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).

Eligibility criteria: * Patients LBC-TJ
* Treated with R-chemotherapy

Primary outcomes:
measure: Describe of mutations in genes
timeFrame: day1
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: Service de Biologie des Tumeurs et Tumorothèque
Study officials:
affiliation: University Hospital, Bordeaux
name: Audrey GROS, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: