COHORT GENOMIC ANNOTATION PLATFORM FOR PHASE I TO III CLINICAL TRIALS (AML/MDS/LEUKEMIA PREDISPOSITION SYNDROMES)
- 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
OPALE entity
CANTHER (UMR-9020/1277)
Contact
Dr. Sandrine PalcyBusiness Development Director