Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07150676

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pediatric Acute Myeloid Leukemia

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Long Term Follow-Up

Other

Long term follow-up as part of standard of care

Primary outcomes

  1. Overall survival

    Time frame: Up to 27 years

Secondary outcomes

  1. Event Free Survival

    Time frame: Up to 27 years

    Event is defined as : relapse, secondary cancer

  2. Cumulative incidence of relapse

    Time frame: Up to 27 years

  3. Cumulative incidence of second cancer

    Time frame: Up to 27 years

  4. Incidence of long-term sequelae

    Time frame: Up to 27 years

    Heart failure, kidney failure, endocrine failure, or any other medical condition covered at 100% by French Social Security

Study contacts

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

Arnaud Petit, MD PhD

CONTACT

[email protected]

+33 1 44 73 63 46 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: DOREMy

Important dates

Study start
2025
Primary completion
2052
Study completion
2052
First posted
Sep 2, 2025
Registry last updated
Sep 2, 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.