Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06956755

Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia

The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The Registry MDS is an ongoing, observational study that has collected longitudinal data on diagnostics, demographics, clinical parameters, and health Care Interventions (HCI) from patients with MDS and therapy-related acute myeloid leukemia.

This registry was created in July 2003 by GFM Group. It is conducted in accordance with the French law on data processing and freedom relating to the processing of personal data in the field of health (law n°78-17 of 6 January 1978 as amended). It has received the favorable opinion of the ethics committee for research and the authorization of the National Commission on Informatics and Freedoms. (CNIL) Included in the registry are all patients over 18 years of age with MDS or secondary chemo- and/or radio-induced leukemia diagnosed after July 2003.

The registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data. Included in the registry are all patients over 18 years of age with MDS or secondary chemo- and/or radio-induced leukemia diagnosed after July 2003.

The registry allows, after obtaining the patient's consent, the anonymous recording of his or her demographic (sex, age), epidemiological (medical and family history, exposure to toxicants), clinical, biological, cytological and cytogenetic data.

To date, 70 GFM centers participate in this registry, 5300 patients have been included. Approximately 400 to 500 new patients are currently included per year.

Data are recorded and entered through the web-based e-CRF by haematology centers in 70 centers of GFM at inclusion and Follow-up of the patients every six months.

Data analyses are conducted by the SBIM (Medical and Biostatistical Computing at service of Pr Sylvie CHEVRET, Hospital Saint Louis). Data quality control including monitoring of both clinical execution and data collection implemented from the initiation of the Registry has resulted in high quality data.

Registry MDS has included the most patients and has proven itself as a well-established operational, and constantly evolving project in an elderly population.

The registration of new patients is still ongoing, and the follow-up of the project is unlimited.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Age > 18 years
  • Patients with myelodysplastic syndrome and therapy-related acute myeloid leukemia
  • Able and willing to provide written informed consent

Exclusion criteria

  • Age <18 years
  • Patient is unwilling or unable to give consent

Treatment and study plan

Primary outcomes

  1. Hemoglobin level Unit of Measure g/dL

    Time frame: At enrollment

    Hemoglobin concentration in patients at the time of inclusion.

  2. Absolute neutrophil count / Unit of Measure G/L

    Time frame: At enrollment

    Neutrophil count measured at baseline

  3. Platelet count Unit of Measure / Unit of Measure: %G/L

    Time frame: At enrollment

    Neutrophil count measured at baseline

  4. Percentage of bone marrow blasts at enrollment / Unit of Measure: percent

    Time frame: At enrollment

    Proportion of blasts in bone marrow aspirate

  5. Presence of multilineage dysplasia at enrollment / Unit of Measure percent of patients

    Time frame: At enrollment

    Number and proportion of patients with multilineage dysplasia

  6. Cytogenetic abnormalities at enrollment / Unit of Measure percent of patients

    Time frame: At enrollment

    Distribution of cytogenetic profiles observed in patients (e.g., normal karyotype, del(5q), complex karyotype, etc.).

  7. IPSS-R risk classification at enrollment / Unit of Measure percent of patients by category

    Time frame: At enrollment

    Number and proportion of patients in each IPSS-R risk category.

  8. Presence of somatic mutations at enrollment / Unit of Measure: percent of patients

    Time frame: At enrollment

    o Description: Frequency of key somatic mutations (e.g., SF3B1, TP53, ASXL1, etc.) identified in included patients

  9. Demographic characteristics at enrollment / Unit of Measure: Descriptive (e.g., mean ± SD for age, % for sex distribution)

    Time frame: At enrollment

    Distribution of age, sex, and other demographic parameters among included patients

Secondary outcomes

  1. Overall survival

    Time frame: From diagnosis until death or last follow-up, up to 120 months

    Time from diagnosis to death from any cause or last follow-up Progression-free survival Bone marrow failure (anemia, neutropenia and thrombocytopenia) Treatment duration and time response Time to IPSS progression, Rate and time to AML evolution Time-to-transfusion dependency Cytogenetic and molecular response

  2. Progression-free survival

    Time frame: From diagnosis until progression, AML transformation, or death, assessed up to 120 months

    Time from diagnosis to progression to higher-risk MDS, transformation to AML, or death from any cause

  3. Incidence of bone marrow failure events (anemia, neutropenia, thrombocytopenia)

    Time frame: From diagnosis until last follow-up, up to 120 months

    Number of patients presenting with hemoglobin <10 g/dL, neutrophils <1.0 G/L, or platelets <100 G/L during follow-up.

  4. Duration of first-line treatment for MDS

    Time frame: From treatment initiation until discontinuation or last follow-up, assessed up to 60 months

    Time from initiation to discontinuation of the first-line therapeutic regimen

  5. Time to first documented treatment response

    Time frame: From treatment start to first response, assessed up to 60 months

    Time from treatment initiation to the first response according to IWG-MDS 2006 criteria.

  6. Time to transformation to acute myeloid leukemia (AML)

    Time frame: From diagnosis until AML confirmation or last follow-up, up to 120 months

    Time from MDS diagnosis to confirmed AML transformation (≥20% blasts in bone marrow).

  7. Time to transfusion dependency

    Time frame: From diagnosis to transfusion dependency or last follow-up, up to 120 months

    Time from diagnosis to the need for regular transfusions, defined as ≥2 units/month for ≥2 consecutive months.

  8. Cytogenetic and molecular response rates

    Time frame: Assessed during follow-up, up to 120 months

    Number and proportion of patients achieving partial or complete cytogenetic and/or molecular responses during follow-up.evaluations.

  9. Time to progression on IPSS score

    Time frame: From initial classification to IPSS progression or last follow-up, up to 120 months

    Time from initial IPSS classification (very low/low) to high or very high-risk category.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatiha CHERMAT, PhD

CONTACT

[email protected]

+33(0)1 71 20 70 59

Pierre FENAUX, Pr

CONTACT

[email protected]

+33 (0) 1 71 20 78 18

Sponsors and collaborators

Lead sponsor

Groupe Francophone des Myelodysplasies

Other

Registry information

Important dates

Study start
2003
Primary completion
2030
Study completion
2031
First posted
May 4, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.