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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 25
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients already included in a protocol or newly included

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Long term follow-up

    Other intervention

    Long term follow-up as part of standard of care

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: All children/young adults (<25 years old) with LAM diagnosed in participating French centers1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time frame
Up to 27 years

Secondary outcomes

1

Event Free Survival

Event is defined as : relapse, secondary cancer

Time frame
Up to 27 years
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

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

Time frame
Up to 27 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: