Informations générales (source: ClinicalTrials.gov)

NCT04286360 En recrutement IDF
Hematological Anomalies in Children With Rasopathy
Observational
  • Malformations
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
novembre 2020
novembre 2029
12 septembre 2025
During childhood, patients with RASopathies (Noonan syndrome and related diseases) can harbor various hematological anomalies ranging from isolated monocytosis, myelemia, thrombocytopenia or splenomegaly to myeloproliferative disorders. These anomalies may spontaneously disappear or persist, sometimes leading to juvenile myelomonocytic leukemia. Guidelines for initial screening and subsequent hematological follow-up have recently been published in France: peripheral blood analysis should be performed in all newly diagnosed patients and followed by biannual peripheral blood analysis in infants until the age of 2 years. In order to describe the characteristics of these abnormalities in terms of their incidence, age of occurrence, evolution and relation to genotype, we are conducting a longitudinal prospective study whose aim is to analyze peripheral blood cell counts and smears at diagnosis and one year later. In patients <3 years of age recruited at certain centers, biobanking of mononuclear cells will be performed. These data could yield a new insight into hematological anomalies in patients with RASopathies and thereby help physicians to determine the appropriate rhythm for hematological follow-up according to genotype.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 13/12/2025 07:43:42  Contacter
AP-HP - Hôpital Armand Trousseau-La Roche Guyon
AP-HP - Hôpital Necker-Enfants Malades
AP-HP - Hôpital Robert Debré
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Angers - Angers - France Estelle Colin, MD En recrutement Contact (sur clinicalTrials)
CHU Caen - Caen - France Marion Gerard, MD En recrutement Contact (sur clinicalTrials)
CHU Lille - Lille - France Anne Dieux Coeslier, MD En recrutement Contact (sur clinicalTrials)
CHU Lyon - Lyon - France Charles Patrick Edery, Pr En recrutement Contact (sur clinicalTrials)
CHU Marseille - Hôpital de la Timone - Marseille - France Sabine Sigaudy, MD En recrutement Contact (sur clinicalTrials)
CHU Montpellier - Montpellier - France David Genevieve, Pr En recrutement Contact (sur clinicalTrials)
CHU Nantes - Nantes - France Bertrand Isidor, MD En recrutement Contact (sur clinicalTrials)
CHU Rennes - Rennes - France Sylvie Odent, Pr En recrutement Contact (sur clinicalTrials)
CHU Strasbourg - Strasbourg - France Elise Scheafer, MD En recrutement Contact (sur clinicalTrials)
CHU Toulouse - Toulouse - France Thomas Edouard, Pr En recrutement Contact (sur clinicalTrials)
Hôpital Robert Debré APHP - Paris - France Marion Strullu, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Age < 16 years

- Patient newly diagnosed with genetically confirmed rasopathy : Noonan syndrome, type
1 neurofibromatosis, Noonan syndrome with multiple lentigines, CBL syndrome,
Costello syndrome, cardiofaciocutaneous syndrome or Legius syndrome i.e. with a
germline mutation of one of these genes: PTPN11, SOS1, NRAS, RAF1, BRAF, SHOC2,
MEK1, MEK2, CBL, NF1, SPRED1, KRAS, HRAS, NF1, SHOC2, LZTR1, SOS2, RIT1, RASA2,
RRAS, PPP1CB, or a new gene of interest published during the recruitment period

- No history of hematological malignancy

- Written informed consent obtained from the parents

- Health insurance



- History of malignant hematological pathology