Harmonized Clinical and Biological Database for Integrated Research Into the Management of Pediatric Acute Myeloid Leukemia

Base de DOnnées Cliniques et Biologiques harmonisées Pour Une REcherche intégrée à la Prise en Charge Des leucémies aiguës Myéloïdes pédiatriques

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07150676

Acronym

DOREMy

Enrollment

2000

Registered

2025-09-02

Start date

2025-10-01

Completion date

2052-10-01

Last updated

2025-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML), Pediatric Acute Myeloid Leukemia

Brief summary

The aim of this project is to study the different diagnostic, predictive, and prognostic profiles, as well as their interrelationships (clinical, biological, genetic) in children with Acute Myeloid Leukemia (AML). Despite numerous research projects on separate cohorts, the prognosis for pediatric AML has not improved. The project therefore consists of pooling research data and existing clinical and biological data from healthcare in a health data warehouse to increase its power. As these diseases are rare and genetic subgroups even rarer, it is crucial to combine all these data sets into a single database to statistically validate our observations. The ultimate goal of this project is to reduce the relapse rate and improve the survival rate of pediatric AML by identifying rare, uncharacterized patient subgroups at high risk of relapse, for whom clinical characteristics and outcomes will be compared with omics data, Leukemia Stem Cells signatures, and drug responses to establish accurate and in-depth profiles.

Interventions

OTHERLong term follow-up

Long term follow-up as part of standard of care

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 25 Years

Healthy volunteers

Inclusion criteria

All patients under the age of 25 diagnosed with AML in the participating centers in France.

Design outcomes

Primary

Measure	Time frame
Overall survival	Up to 27 years

Secondary

Measure	Time frame	Description
Event Free Survival	Up to 27 years	Event is defined as : relapse, secondary cancer
Cumulative incidence of relapse	Up to 27 years	—
Cumulative incidence of second cancer	Up to 27 years	—
Incidence of long-term sequelae	Up to 27 years	Heart failure, kidney failure, endocrine failure, or any other medical condition covered at 100% by French Social Security

Contacts

Primary ContactArnaud Petit, MD PhD

arnaud.petit@aphp.fr+33 1 44 73 63 46

Backup ContactJérôme Lambert, MD PhD

jerome.lambert@u-paris.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026