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Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation

Study acronym: GATA-2
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 23 to 24
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Study sites: 19 to 23v18
  3. Primary and study completion dates: Oct 2033 to Dec 2033v17
  4. Site details revised at 2 of 19 sitesv16
  5. Study sites: 18 to 19v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 2 of 18 sitesv14
  2. Site details revised at 1 of 18 sitesv13
  3. Site details revised at 1 of 18 sitesv12
  4. Site details revised at 1 of 18 sitesv11
  5. Site details revised at 1 of 18 sitesv10
  6. Site details revised at 1 of 18 sitesv9
  7. Site details revised at 1 of 18 sitesv8
  8. Site details revised at 5 of 18 sitesv7
  9. Study sites: 17 to 18v6
  10. Start date changed from estimate of Dec 2023 to Dec 7, 2023v5
  11. Start date: Nov 2023 to Dec 2023v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2023 to Nov 2023
    • Site details revised at 17 of 17 sites
    v3
  13. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial is a translational, open-label, multi-site, retrospective and prospective cohort study of 250 patients aiming to characterize predictive parameters of clonal evolution in a population of subjects carrying the germline GATA2 mutation. This study will be conducted on a population of subjects either with previous germline GATA2 mutation identified or newly identified for germline GATA2 mutation in the context of routine care. Prospective cohort: 150 subjects will be included in this interventional prospective cohort study: * Alive subjects previously identified with a germline GATA2 mutation through the already existing "Neutropenia database"; * Subject identified in the investigating centers in the context of a newly identified germline GATA2 mutation. For each included patient, biological samples (blood and bone marrow samples) will be collected at baseline visit and then during 5 years, according to the samples taken in the standard practice. No additional sampling will be performed for the study. Retrospective cohort: Subjects (100 cases in total) previously identified with germline GATA2 mutation through the already existing "Neutropenia database" and with the following features may enter the retrospective cohort: * Deceased patients, * Lost to follow-up patients. Clinical follow-up data will be obtained from this database and/or patient's medical report. For each retrospective case, archived blood and bone marrow samples (collected in a sanitary setting) will be sent to sponsor's centralized unit for analysis.
Trial Details
NCT Number NCT05983991
Lead Sponsor Institut Claudius Regaud
Conditions
(from sponsor)		 GATA2 Gene Mutation
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov