Clinical trial NCT06681363: Creation of a Biocollection of Patients with Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelodysplastic Syndrome (MDS) Monitored At the Nantes University Hospital
Official title: Creation of a Biocollection of Patients with Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelodysplastic Syndrome (MDS) Monitored At the Nantes University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myeloid Leucemia
High-risk Myelodysplastic Syndrome (MDS)
Acute Lymphoid Leukemia
Keywords: high-risk myelodysplactic syndrome
Acute leukemia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high-risk AML, ALL, or MDS managed in the hematology department of the University Hospital of Nantes

Brief summary: The aim of the LANA bio-collection is to collect samples from patients with Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL) or or high-risk myelodysplastic syndrome (MDS) to facilitate access to the leukemic or myelodysplastic cells for the research teams of the National Institute of Health and Medical Research (INSERM). To do this, an additional blood or bone marrow sample to those planned in the context of patient care will be collected after signing consent. These samples will then be sent directly to the INSERM teams for immediate analysis with the aim to conduct research aimed at a better understanding of AML, ALL or MDS and improving treatments

Detailed description: The main objective of the prospective and monocentric LANA biocollection is to characterize the tumor and its microenvironment in Acute Lymphocytic Leukemia (ALL) or Acute Myeloid Leukemia (AML) or high-risk myelodysplastic syndrome (MDS) in order to identify new biomarkers or therapeutic targets. Blood and bone marrow of patients included in the LANA bio-collection will be used to search for genetic polymorphisms linked to an increased risk of developing AML or ALL and on the analysis of the evolution of plasma concentrations of a wide range of cytokines. This approach will involve an in-depth study of their transcriptome, followed by the validation of cell populations and potential therapeutic targets by multiparametric flow cytometry on fresh samples.

The LANA bio-collection will be proposed by a physician to patients regardless of the stage of the disease. The inclusion in the biocollection will be effective following the signing of the consent form. An additional volume of blood and bone marrow samples will be taken only if these sampling are already planned in the patient care and without any additional puncture being performed. Sampling will not be taken on a recurring basis but, according to the needs of ongoing biological studies, additional samples may be collected, with up to one additional sample each month for three months following inclusion. Blood and bone marrow samples will be taken at the time of inclusion (for diagnosis or relapse) and, based on the results of the first analyses of the laboratories of research partners, it is possible that the biological materials available in the initial samples are not sufficient to continue the explorations. In this case, the laboratory will contact the clinic service for a new addition of blood or medullary samples collected during patient care. The collected samples will either be sent directly to the partner research laboratories or, if not sent immediately, will be stored in the laboratory dedicated to clinical research sample processing within the clinical hematology department of Nantes University Hospital, under the responsibility of the principal investigator.

Eligibility criteria: Inclusion Criteria:

* Patient of legal age affected by AML, ALL or MDS regardless of the time of treatment
* Patient who has signed the consent form.
* Patient affiliated with a social security system.

Exclusion Criteria:

* Minor patients.
* Adults under guardianship.
* Protected persons

Primary outcomes:
measure: Characterization of the tumor and its microenvironment for AML, ALL or MDS in order to identify novel biomarkers or therapeutic targets
timeFrame: One year after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Pierre Peterlin
role: PRINCIPAL_INVESTIGATOR
References: