Registry of Myelodysplastic Syndromes and Therapy-related Acute Myeloid Leukemia

NCT ID: NCT06956755

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6990 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-07-07
• Study Completion Date: 2031-01-05

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

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.

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Study Design

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

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Francophone des Myelodysplasies

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aspasia Stamatoullas

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fatiha CHERMAT, PhD

Role: CONTACT

fatiha.chermat-ext@aphp.fr

+33(0)1 71 20 70 59

Pierre FENAUX, Pr

Role: CONTACT

pierre.fenaux@aphp.fr

+33 (0) 1 71 20 78 18

Facility Contacts

aspasia stamatoullas, MD

Role: primary

spasia.stamatoullas@chb.unicancer.fr

02 32 08 22 88

Other Identifiers

GFM-MDS Registry

Identifier Type: -

Identifier Source: org_study_id