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Not yet recruiting NCT06175923

Role of BMP Pathway in MDS Progression

— Observational Myelodysplastic Syndromes Acute Myelogenous Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collection of EDTA (disodium salt of ethylenediaminetetraacetic acid) tubes of marrow during routine care.
Who it may be relevant to
Registry conditions: Myelodysplastic Syndromes, Acute Myelogenous Leukemia. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Role of the BMP Pathway in Myelodysplastic Syndromes Progression and in the Transition to Acute Myeloid Leukemia

Overview

Myelodysplastic syndromes (MDS) are hematological cancers that can progress to acute myelogenous leukemia (AML). The involvement of the microenvironment in the maintenance, resistance and evolution of MDS is increasingly described. The Bone Morphogenetic Protein (BMP) pathway is involved in numerous functions, including self-renewal of the hematopoietic stem cell compartment and the regulation of hematopoiesis, via interaction with bone marrow stromal cells. Investigators have demonstrated its involvement in chronic myeloid leukemia (CML) and AML, in particular via the activation of TWIST1, ΔNp73, NANOG; it is responsible for an increased state of quiescence of certain cancer stem cells and their resistance. Preliminary results based on the analysis of large databases suggest that the BMP pathway is also altered early in MDS. This study explores the alteration of this pathway in MDS and its involvement in the transformation into AML. If appropriate, the BMP pathway could constitute a very promising therapeutic target to combat transformation into AML.

Interventions

  • Biological Collection of EDTA (disodium salt of ethylenediaminetetraacetic acid) tubes of marrow during routine care
    When bone marrow is collected as part of a patient's care (diagnosis, follow-up, suspected AML/MDS hemopathy), one or two additional EDTA tubes of marrow are collected. Certain hematological data (NFP, genetic and molecular characteristics) will be collected in anonymized form and correlated with the BMP pathway alterations measured.

Primary outcome measures

  • Descriptive analysis of the BMP pathway : Bone marrow plasma BMP2/BMP4 levels [Time frame: at diagnosis, at 6 months, at 5 years]
  • Descriptive analysis of the BMP pathway : Bone marrow mononuclear cell fraction [Time frame: at diagnosis, at 6 months, at 5 years]
  • Descriptive analysis of the BMP pathway : - Bone marrow mesenchymal stem cells number and differentiation capacities after passage 0 - Functional level [Time frame: at diagnosis, at 6 months, at 5 years]
  • Descriptive analysis of the BMP pathway : - Bone marrow mesenchymal stem cells number and differentiation capacities after passage 0 - Transcriptomic level [Time frame: at diagnosis, at 6 months, at 5 years]
  • Descriptive analysis of the BMP pathway : - Bone marrow mesenchymal stem cells number and differentiation capacities after passage 0 - Protein level [Time frame: at diagnosis, at 6 months, at 5 years]

Eligibility criteria

Inclusion criteria

  • Adult patients with myelodysplastic syndrome or suspected myelodysplastic syndrome according to the criteria defined by the World Health Organization Or
  • Adult patient with suspicion of de novo acute myeloid leukemia at initial treatment

Exclusion criteria

  • Frontier MDS/myeloproliferative syndromes including chronic myelomonocytic leukemia
  • MDS and AML having already benefited from cytotoxic treatment including hydroxycarbamide, azacytidine, intensive chemotherapy
  • Patients objecting to their inclusion in the study
  • Pregnant or breastfeeding women
  • Patients under legal protection measure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hospices Civils de Lyon — Lyon

Identifiers

NCT: NCT06175923 · 69HCL22_0491

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗