Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation
- Conditions
- GATA2 Gene Mutation
- Registration Number
- NCT05983991
- Lead Sponsor
- Institut Claudius Regaud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria:<br><br> 1. All subject, at any age, with a germline GATA2 mutation.<br><br> 2. Patient followed in the center within a standard of care procedure or clinical<br> trial.<br><br> 3. Signed written informed consent. For minor patients: patient assent and legal<br> guardian(s) written informed consent obtained before inclusion in the study and<br> prior performance of any study-related procedure.<br><br> 4. For French patients: patient affiliated to a Social Health Insurance.<br><br>Exclusion Criteria:<br><br> 1. GATA2 somatic mutation.<br><br> 2. Any psychological, familial, geographic or social situation, according to the<br> judgment of investigator, potentially preventing the provision of informed consent<br> or compliance to study procedure.<br><br> 3. Person who has forfeited his/her freedom by administrative or legal award or who is<br> under legal protection, with the exception of persons under curatorship who may be<br> included in the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to appearance of spectrum 2, defined as the delay between date of birth and appearance of an event classified as spectrum 2.
- Secondary Outcome Measures
Name Time Method Time to appearance of spectrum 1, defined as the delay between date of birth and appearance of spectrum 1.;Time to appearance of first hematological event defined by the delay between date of birth and appearance of first hematological.;Disease Free Survival (DFS) defined as the time from Leukemia diagnosis until first /relapse or death from any cause.