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 (LANA)
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Pierre Perterlin
- Phone Number: +33 2 40 08 32 71
- Email: Pierre.PETERLIN@chu-nantes.fr
Study Locations
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Nantes, France
- Recruiting
- Nantes University Hospital
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Contact:
- Nicoletta Libera LILLI
- Phone Number: +33 2 76 64 37 83
- Email: nicolettalibera.lilli@chu-nantes.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with high-risk AML, ALL or MDS
Patients with high-risk AML, ALL or MDS treated in the hematology department of Nantes University Hospital. According to the needs of ongoing biological studies, additional volumes may be collected during blood and bone marrow sampling for diagnosis or relapse at inclusion , with up to one additional sample each month for three months following inclusion |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Characterization of the tumor and its microenvironment for AML, ALL or MDS in order to identify novel biomarkers or therapeutic targets
Time Frame: One year after inclusion
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Identify genetic polymorphisms associated with an increased risk of developing AML or ALL
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One year after inclusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre Peterlin, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC24_0483
- 2024-A1986-41 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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