Harmonized Clinical and Biological Database for Integrated Research Into the Management of Pediatric Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Long term follow-up.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia (AML), Pediatric Acute Myeloid Leukemia. Basic parameters: up to 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Base de DOnnées Cliniques et Biologiques harmonisées Pour Une REcherche intégrée à la Prise en Charge Des leucémies aiguës Myéloïdes pédiatriques
Overview
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
- Other Long term follow-up
Long term follow-up as part of standard of care
Primary outcome measures
- Overall survival [Time frame: Up to 27 years]
Secondary outcome measures (4)
- Event Free Survival [Time frame: Up to 27 years]
- Cumulative incidence of relapse [Time frame: Up to 27 years]
- Cumulative incidence of second cancer [Time frame: Up to 27 years]
- Incidence of long-term sequelae [Time frame: Up to 27 years]
Eligibility criteria
All patients under the age of 25 diagnosed with AML in the participating centers in France.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07150676 · APHP210144