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

NCT04183569 | Unknown

• 1 other identifier: CHUBX 2018/78
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, Large B-Cell, Diffuse

Keywords

Proteomic; Mutations; Predictive marker; Rituximab-polychemotherapy; Integrative bioinformatics tool

Outcome Measures

Primary Outcomes (1)

• 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.

  day1

Study Arms (1)

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.

Interventions

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

Primary diffuse cutaneous B-cell lymphoma, leg type

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* Patients LBC-TJ * Treated with R-chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service de Biologie des Tumeurs et Tumorothèque

Pessac, 33600, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

skin biopsies

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Audrey GROS, PharmD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: February 19, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)