• Clinical development
  • AML
  • MDS
  • Leukemia predisposition syndromes
  • Targeted therapy
  • Immunotherapy
  • Clinical research (TRL 6-8)

The Lille University Hospital Hematology Laboratory provides molecular biology expertise for systematic annotation of patient samples in clinical trials.

The laboratory has expertise in annotating the cohorts of academic cooperative groups.


Description

Scope of research activities

Clinical research into AML, MDS and ARCH (age-related clonal hematopoiesis) pathologies, with the aim of improving patient care and quality of life:

  • Interventional clinical research

Role 

  • Participation in establishing clinical protocol
  • Analysis design
  • Organization, implementation and conduct of analyses
  • Interpretation and communication of results

Infrastructure 

Experimental and analysis platforms:

  • Genomics (Novaseq sequencer)

Models:

  • Primary cells from clinical study patients

Technical personnel:

  • Qualified personnel: engineers, laboratory technicians, molecular biologists
  • Bioinformatics support: Bioinformatics team at the common molecular biology platform of the Centre de Biologie Pathologie at Lille University Hospital (in partnership)

Specifications

The platform

Standardized genomic analysis platform for annotating patient samples in Phase I to III clinical trials:

  • Complete myeloid NGS panel (100 genes)

The studies 

Genomic analysis:

  • Identification of nucleotide variations and DNA insertions/deletions
  • Sensitivity threshold 2% mutated cells

Measurement of residual disease:

  • Monitoring of a previously identified genetic marker 
  • Threshold varies according to technique used (10-4 to 10-6)

Examples of partnerships

Genomic annotation of the ALFA-0702 cohort (young adult AML) - The aim of this study was to identify molecular abnormalities in young adult AML and to monitor residual disease during treatment in order to establish a prognostic stratification model based on a "knowledge bank" approach.

Partner: ALFA Group

Genomic annotation of the AZA-PLUS cohort (high-risk MDS) - This study aimed to identify molecular abnormalities in high-risk MDS and define the impact of the various therapies proposed in the molecular subgroups.

Partner: GFM


Terms

  • Clinical research project with industrial sponsoring
  • Partnership agreement with study sponsor
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