Interplay Between Immune and Metabolic Programs in Myelodysplastic Syndromes

NCT ID: NCT04803721

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 137 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2024-01-01

Brief Summary

Myelodysplastic syndromes (MDS) are a pre-leukemic condition with an extremely poor prognosis despite current treatments that justify new therapeutic approaches. Various studies have described the potential involvement of both immune compartment and cellular metabolism in the pathophysiology of MDS. The aim of this study is to determine the specific immune and metabolic profiles of the different classes of MDS and to identify predictive markers of progression/survival/response to therapy.

Detailed Description

Myelodysplastic syndromes (MDS) are a pre-leukemic condition with an extremely poor prognosis despite current treatments. It is the most frequent haematological disorder after the age of 65. Different approaches targeting the immune compartment have been developed but preliminary results seem to show variable response rates to these therapeutic highlighting the heterogeneity of MDS and the need to identify detailed immune profiles that are predictive of disease progression and can help in treatment choices. It therefore seems essential to complement the knowledge of immune profiles with an understanding of the metabolic profiles of MDS patients, as well as the links between these profiles and changes associated with progression and/or treatment resistance, in order to consider new therapeutic pathways.

Fresh samples from patients with MDS will be used to perform flow cytometry mapping of immune populations, T-cell and blast cell metabolism. Subsequently, a study of energy metabolism will be conducted using an extracellular flow analyzer and a sensitivity test for certain molecules targeting metabolic pathways. If possible, samples will be taken at different times during the course of treatment, according to the therapeutic protocols: diagnosis, progression/transformation, during azacitidine treatment.

Conditions

Myelodysplastic Syndromes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with a myelodysplastic syndrome

Patient over 18 years of age with a myelodysplastic syndrome (WHO 2016 classification) of low risk (LR= International Prognostic Scoring System (IPSS)-R\<4.5) or high risk (HR=Revised International Prognostic Scoring System\>4.5)

No interventions assigned to this group

Control patient

Healthy blood donor (regardless of age) Or Patient \>60 years old, see at the geriatrics platform of the hospital la Grave (CHU of Toulouse), having expressed his non opposition to participate in the study

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients:

• Patient over 18 years of age with a myelodysplastic syndrome (WHO 2016 classification) of low risk (LR=IPSS-R<4.5) or high risk (HR=IPSS-R>4.5);
• Patient naïve to specific treatment of MDS;
• Patient who expressed no opposition to participating in the study. ;
• Patient affiliated with the social security system.
• Control:

• over 18 years of age,
• Sample from blood donation (regardless of age) Or Patient >60 years old, see at the geriatrics platform of the hospital la Grave (CHU of Toulouse),
• having expressed his non opposition to participate in the study

Exclusion Criteria

• Patients:

• Myeloid disease other than MDS (including chronic myelomonocytic leukemia and MDS/SMP) ;
• Ongoing treatments for MDS (excluding erythropoietin, granulocyte colony-stimulating factor and transfusions) ;
• Medical conditions that may interfere with immune system testing: active cancer, active autoimmune disease, inflammatory conditions, immunosuppressive therapy. ; * Pregnant or breastfeeding women ; Patient's refusal ;
• Person benefiting from a system of protection for adults (including guardianship, curators and safeguarding of justice)
• Control:

• Medical conditions that may interfere with immune system testing: active cancer, active autoimmune disease, inflammatory conditions, immunosuppressive therapy. ; * Pregnant or breastfeeding women ;
• Patient's refusal ;
• Person benefiting from a system of protection for adults (including guardianship, curators and safeguarding of justice)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thibault Comont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

IUCT-Oncopole University Hospital

Toulouse, , France

Countries

France

Other Identifiers

RC31/20/0481

Identifier Type: -

Identifier Source: org_study_id