Acute Myeloid Leukemia (AML)DOREMyNCT07150676
Harmonized Clinical and Biological Database for Integrated Research Into the Management of Pediatric Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia (AML) and Pediatric Acute Myeloid Leukemia, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Pediatric Acute Myeloid Leukemia
- What is being tested?
- Long term follow-up
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2052
- How long will I take part?
- 27 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jérôme Lambert, MD PhD contact
About this study
Official title: Base de DOnnées Cliniques et Biologiques harmonisées Pour Une REcherche intégrée à la Prise en Charge Des leucémies aiguës Myéloïdes pédiatriques
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.
Read more
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.
- Being tested
- Long term follow-up
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term follow-upOther
Long term follow-up as part of standard of care
| Study group | Role | What they receive |
|---|---|---|
| All children/young adults (<25 years old) with LAM diagnosed in participating French centers | Not described Receives: Other: Long term follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 27 years
Secondary outcomes (4)
Event Free Survival
Event is defined as : relapse, secondary cancer
Measured: Up to 27 years
Cumulative incidence of relapse
Measured: Up to 27 years
Cumulative incidence of second cancer
Measured: Up to 27 years
Incidence of long-term sequelae
Heart failure, kidney failure, endocrine failure, or any other medical condition covered at 100% by French Social Security
Measured: Up to 27 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2052 (estimated)
- Study completion1 Oct 2052 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 27 Years
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150676
- Sponsor's protocol ID
- APHP210144
- Acronym
- DOREMy
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Base de DOnnées Cliniques et Biologiques harmonisées Pour Une REcherche intégrée à la Prise en Charge Des leucémies aiguës Myéloïdes pédiatriques
- ClinicalTrials.gov ID
- NCT07150676
- Acronym / sponsor ID
- DOREMy / APHP210144
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2052 (estimated)
- Study completion
- 1 Oct 2052 (estimated)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 27 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All children/young adults (<25 years old) with LAM diagnosed in participating French centers | – | Other: Long term follow-up |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients already included in a protocol or newly included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long term follow-upLong term follow-up as part of standard of care | Other | All children/young adults (<25 years old) with LAM diagnosed in participating French centers |
Primary outcome
Overall survival
Time frame: Up to 27 years
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jérôme Lambert, MD PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML) and Pediatric Acute Myeloid Leukemia, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Petit, MD PhD (+33 1 44 73 63 46 ext. +33, arnaud.petit@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 27 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.