Interplay Between Immune and Metabolic Programs in Myelodysplastic Syndromes

NCT04803721 | Completed

• 1 other identifier: RC31/20/0481
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndromes

Keywords

Myelodysplastic syndromes; T-cells; metabolism

Outcome Measures

Primary Outcomes (1)

• Immune and metabolic profiles will be evaluated by immunophenotyping

  phenotypic study of one or more leukocyte sub-populations by flow cytometry

  Day 0

Secondary Outcomes (1)

• Identification of time to progression/transformation and time to death

  Day 0 and through study completion, an average of 1 year

Study Arms (2)

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)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with a myelodysplastic syndrome (WHO 2016 classification) of low risk (LR=IPSS-R\<4.5) or high risk (HR=IPSS-R\>4.5)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

IUCT-Oncopole University Hospital

Toulouse, 31500, France

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Thibault Comont, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: February 23, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Locations

FR (1)