Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation
NCT ID: NCT05983991
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-12-07
2033-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Subject with a germline GATA2 mutation (Interventional prospective cohort)
Biological samples (blood and bone marrow samples).
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.
Interventions
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Biological samples (blood and bone marrow samples).
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.
Eligibility Criteria
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Inclusion Criteria
2. Patient followed in the center within a standard of care procedure or clinical trial.
3. Signed written informed consent. For minor patients: patient assent and legal guardian(s) written informed consent obtained before inclusion in the study and prior performance of any study-related procedure.
4. For French patients: patient affiliated to a Social Health Insurance.
Exclusion Criteria
2. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
3. Person who has forfeited his/her freedom by administrative or legal award or who is under legal protection, with the exception of persons under curatorship who may be included in the study.
ALL
Yes
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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CHU Angers
Angers, , France
CHU Bordeaux
Bordeaux, , France
CHU Estaing
Clermont-Ferrand, , France
CHU Dijon
Dijon, , France
CHU de Grenoble
Grenoble, , France
CHRU - Lille
Lille, , France
IHOP Lyon
Lyon, , France
CHU La Timone
Marseille, , France
CHU Arnaud de Villeneuve
Montpellier, , France
CHU Nantes
Nantes, , France
CHU de Nice
Nice, , France
Hôpital Armand Trousseau
Paris, , France
Hôpital Robert Debré
Paris, , France
Hôpital Saint-Louis
Paris, , France
CHU Rennes
Rennes, , France
CHU Hôpitaux de Rouen - Charles Nicolle
Rouen, , France
CHU Saint-Etienne
Saint-Priest-en-Jarez, , France
Hôpital Necker
Sèvres, , France
CHU Strasbourg
Strasbourg, , France
CHU Purpan - Hôpital des Enfants
Toulouse, , France
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
Toulouse, , France
CHRU de Tours
Tours, , France
CHRU Nancy Hôpital d'enfants
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Sylvie FRANCOIS
Role: primary
Pierre-Yves DUMAS
Role: primary
Justyna KANOLD
Role: primary
Florent NEUMANN
Role: primary
Claire FREYCON, MD
Role: primary
Louis TERRIOU
Role: primary
Cécile RENARD
Role: primary
Vincent BARLOGIS
Role: primary
Eric JEZIORSKI
Role: primary
Caroline THOMAS
Role: primary
Pierre-Simon ROHRLICH, MD
Role: primary
Jean DONADIEU
Role: primary
Saba AZARNOUSH
Role: primary
Claire FIESCHI
Role: primary
Virginie GANDEMER
Role: primary
Nimrod BUCHBINDER
Role: primary
Jérôme CORNILLON
Role: primary
Felipe SUAREZ, MD
Role: primary
Catherine PAILLARD
Role: primary
Marlène PASQUET
Role: primary
Pierre VANDE PERRE
Role: primary
Alban VILLATE, MD
Role: primary
Maude GAFFET
Role: primary
Other Identifiers
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22 HEMA 21
Identifier Type: -
Identifier Source: org_study_id