NCT06956755

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,990

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2003Jan 2031

Study Start

First participant enrolled

July 7, 2003

Completed
21.7 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2031

Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

26.5 years

First QC Date

March 5, 2025

Last Update Submit

May 2, 2025

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Keywords

MDSt-AML

Outcome Measures

Primary Outcomes (9)

  • Hemoglobin level Unit of Measure g/dL

    Hemoglobin concentration in patients at the time of inclusion.

    At enrollment

  • Absolute neutrophil count / Unit of Measure G/L

    Neutrophil count measured at baseline

    At enrollment

  • Platelet count Unit of Measure / Unit of Measure: %G/L

    Neutrophil count measured at baseline

    At enrollment

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

    Proportion of blasts in bone marrow aspirate

    At enrollment

  • Presence of multilineage dysplasia at enrollment / Unit of Measure percent of patients

    Number and proportion of patients with multilineage dysplasia

    At enrollment

  • 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.).

    At enrollment

  • 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.

    At enrollment

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

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

    At enrollment

  • 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

    At enrollment

Secondary Outcomes (9)

  • Overall survival

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

  • Progression-free survival

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

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

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

  • Duration of first-line treatment for MDS

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

  • Time to first documented treatment response

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

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspasia Stamatoullas

Rouen, 76038, France

RECRUITING

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Fatiha CHERMAT, PhD

CONTACT

+33(0)1 71 20 70 59fatiha.chermat-ext@aphp.fr

Pierre FENAUX, Pr

CONTACT

+33 (0) 1 71 20 78 18pierre.fenaux@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

May 4, 2025

Study Start

July 7, 2003

Primary Completion (Estimated)

January 5, 2030

Study Completion (Estimated)

January 5, 2031

Last Updated

May 6, 2025

Record last verified: 2025-04

Locations

FR(1)