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Myelodysplastic SyndromesNCT06956755

Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia

An observational study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Groupe Francophone des Myelodysplasies at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
How many people
6,990 participants
Where
1 siteFrance
Study dates
7 Jul 2003to 5 Jan 2031
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Included in the "Registry" are all patients over 18 years of age with myelodysplastic syndrome and therapy-related acute myeloid leukemia

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatiha CHERMAT, PhD contact

+33(0)1 71 20 70 59

fatiha.chermat-ext@aphp.fr

Pierre FENAUX, Pr contact

+33 (0) 1 71 20 78 18

pierre.fenaux@aphp.fr

France1 site, 1 recruiting

  • Aspasia Stamatoullas

    Rouen, 76038

    aspasia stamatoullas, MD, 02 32 08 22 88, spasia.stamatoullas@chb.unicancer.fr

    Recruiting

Other trials in France

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

Read the detailed description

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.

Keywords
MDS, t-AML
Medical subject headings
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin level Unit of Measure g/dL

    Hemoglobin concentration in patients at the time of inclusion.

    Measured: At enrollment

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

    Neutrophil count measured at baseline

    Measured: At enrollment

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

    Neutrophil count measured at baseline

    Measured: At enrollment

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

    Proportion of blasts in bone marrow aspirate

    Measured: At enrollment

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

    Number and proportion of patients with multilineage dysplasia

    Measured: At enrollment

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

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

    Measured: At enrollment

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

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

    Measured: At enrollment

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

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

    Measured: At enrollment

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

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

    Measured: At enrollment

Secondary outcomes (9)

  1. Overall survival

    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

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

  2. Progression-free survival

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

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

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

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

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

  4. Duration of first-line treatment for MDS

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

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

  5. Time to first documented treatment response

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

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

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

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

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

  7. Time to transfusion dependency

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

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

  8. Cytogenetic and molecular response rates

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

    Measured: Assessed during follow-up, up to 120 months

  9. Time to progression on IPSS score

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2025
  2. Study start7 Jul 2003
  3. Primary completion5 Jan 2030 (estimated)
  4. Study completion5 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,990 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956755
Sponsor's protocol ID
GFM-MDS Registry
Status last verified
Sep 2026
First submitted
5 Mar 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic Syndromes and Leukemia, Myeloid, Acute, run by Groupe Francophone des Myelodysplasies at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fatiha CHERMAT, PhD (+33(0)1 71 20 70 59, fatiha.chermat-ext@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin level Unit of Measure g/dL (time frame: At enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06956755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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