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

NCT07150676 | Not Yet Recruiting

• 1 other identifier: APHP210144
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Myeloid Leukemia (AML); Pediatric Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Up to 27 years

Secondary Outcomes (4)

• Event Free Survival

  Up to 27 years

• 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

Study Arms (1)

All children/young adults (<25 years old) with LAM diagnosed in participating French centers

Other: Long term follow-up

Interventions

Long term follow-up OTHER

Long term follow-up as part of standard of care

All children/young adults (<25 years old) with LAM diagnosed in participating French centers

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients already included in a protocol or newly included

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Arnaud Petit, MD PhD

CONTACT

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

Jérôme Lambert, MD PhD

CONTACT

jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 27 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2052
• Study Completion (Estimated): October 1, 2052
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share