GATA-2 Project: Retrospective and Prospective Exploratory Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• All subject, at any age, with a germline GATA2 mutation.

• Patient followed in the center within a standard of care procedure or clinical trial.

• 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.

• For French patients: patient affiliated to a Social Health Insurance.

Locations
Other Locations
France
CHU Angers
RECRUITING
Angers
CHU Bordeaux
RECRUITING
Bordeaux
CHU Estaing
RECRUITING
Clermont-ferrand
CHU Dijon
RECRUITING
Dijon
CHRU - Lille
RECRUITING
Lille
IHOP Lyon
RECRUITING
Lyon
CHU La Timone
NOT_YET_RECRUITING
Marseille
CHU Arnaud de Villeneuve
RECRUITING
Montpellier
CHU Nantes
RECRUITING
Nantes
Hôpital Armand Trousseau
RECRUITING
Paris
Hôpital Robert Debré
RECRUITING
Paris
Hôpital Saint-Louis
RECRUITING
Paris
CHU Rennes
RECRUITING
Rennes
CHU Hôpitaux de Rouen - Charles Nicolle
RECRUITING
Rouen
CHU Saint-Etienne
RECRUITING
Saint-priest-en-jarez
CHU Strasbourg
RECRUITING
Strasbourg
CHU Purpan - Hôpital des Enfants
RECRUITING
Toulouse
Institut Universitaire Du Cancer Toulouse - Oncopole (Iuct-O)
RECRUITING
Toulouse
CHRU Nancy Hôpital d'enfants
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Marlène PASQUET
pasquet.m@chu-toulouse.fr
+33 5 34 55 86 08
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2033-12
Participants
Target number of participants: 150
Treatments
Experimental: Subject with a germline GATA2 mutation (Interventional prospective cohort)
Related Therapeutic Areas
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov