Clinical trial NCT02516579: European Sickle Cell Disease Cohort - Hydroxyurea
Official title: ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Lead sponsor: Theravia
Sponsor class: INDUSTRY
First posted: 2015-08-06
Enrollment: 1906
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with sickle-cell disease

Brief summary: In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.


Eligibility criteria: Inclusion Criteria:

* Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults)
* With symptomatic sickle cell syndrome
* Treated with Siklos®
* Having been informed of the study by the initiating physician and consenting to participate to the cohort.

Primary outcomes:
measure: % of Patient-years With Malignancies
timeFrame: During the follow-up of participant, up to 10 years
measure: % of Patient-years With Skin Ulcerations
timeFrame: During the follow-up of participant, up to 10 years
measure: % of Patient-years With Myelosuppressions
timeFrame: During the follow-up of participant, up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens - Picardie - Site sud
city: Aulnay-sous-Bois
country: France
facility: Centre Hospitalier Robert Ballanger, pédiatrie et néonatalogie
city: Bobigny
country: France
facility: Hôpital Avicenne; médecine interne
city: Bondy
country: France
facility: Hôpital Jean Verdier; médecine interne
city: Bondy
country: France
facility: Hôpital Jean Verdier; pédiatrie
city: Bordeaux
country: France
facility: CHU Bordeaux, urgences pédiatriques
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Clermont Ferrand
country: France
facility: CHU Estaing, pédiatrie
city: Colombes
country: France
facility: Hôpital Louis Mourier; pédiatrie
city: Colombes
country: France
facility: Hôpital Louis Mourier; service de pédiatrie
city: Créteil
country: France
facility: Centre hospitalier intercommunal de Créteil
city: Créteil
country: France
facility: Hôpital Henri Mondor, centre de la Drépanocytose
city: Gonesse
country: France
facility: Centre Hospitalier de Gonesse, médecine interne
city: Gonesse
country: France
facility: Centre Hospitalier de Gonesse, pédiatrie
city: Grenoble
country: France
facility: CHU de Grenoble, hôpital Couple Enfant
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Limoges
country: France
facility: Hôpital Mère-Enfant
city: Lyon
country: France
facility: Hôpital Edouard Herriot, hémovigilance
city: Lyon
country: France
facility: Institut d'Hématologie et d'Oncologie Pédiatrique
city: Marseille
country: France
facility: CHU Timone
city: Marseille
country: France
facility: Hôpital de la Conception, médecine interne
city: Montreuil-sous-Bois
country: France
facility: Centre Hospitalier Intercommunal André Grégoire
city: Nantes
country: France
facility: CHU Nantes, Hôpital Hôtel Dieu
city: Paris
country: France
facility: Hôpital Trousseau; pédiatrie générale
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Necker enfants, maladies infectieuses et tropicales
city: Paris
country: France
facility: Hôpital Necker; biothérapie
city: Paris
country: France
facility: Hôpital Necker; maladies infectieuses et tropicales
city: Paris
country: France
facility: Hôpital Robert Debré, immunologie-hématologie pédiatrique
city: Reims
country: France
facility: CHR Reims, American Memorial Hospital
city: Rennes
country: France
facility: CHU Rennes, Hôpital Pontchaillou
city: Rennes
country: France
facility: CHU Rennes, hôpital Sud
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Saint-Denis
country: France
facility: Centre Hospitalier Delafontaine, médecine interne
city: Saint-Denis
country: France
facility: Centre Hospitalier Delafontaine, pédiatrie
city: Strasbourg
country: France
facility: CHRU Strasbourg, Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU Toulouse; hôpital des enfants
city: Toulouse
country: France
facility: Institut Universitaire du cancer; médecine interne
city: Vandoeuvre-lès-Nancy
country: France
facility: CHU Nancy, Brabois enfants
city: Cayenne
country: French Guiana
facility: CH André Rosemon
city: Kourou
country: French Guiana
facility: CMCK
city: Saint Laurent du Maroni
country: French Guiana
facility: CH Ouest Guyanais
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin, Berlin
city: Delmenhorst
country: Germany
facility: Pädiatrie Klinikum Delmenhorst
city: Düsseldorf
country: Germany
facility: Heinrich-Heine Universität Düsseldorf
city: Freiburg
country: Germany
facility: University of Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: München
country: Germany
facility: München
city: Athens
country: Greece
facility: Laiko General Hospital
city: Basse-Terre
country: Guadeloupe
facility: CH Basse-Terre, adultes
city: Basse-Terre
country: Guadeloupe
facility: CH Basse-Terre, enfants
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU Pointe à Pitre
city: Napoli
country: Italy
facility: Clinica Pediatrica AOU
city: Padova
country: Italy
facility: Azienda Ospedaliera-University of Padova
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata (AOUI Verona)
city: Fort de France
country: Martinique
facility: CHU Fort de France
city: Fort de France
country: Martinique
facility: Hôpital Pierre Zobda-Quitman
city: Le Lamentin
country: Martinique
facility: CH Lamentin
Study officials:
affiliation: Hôpital henri Mondor (Adults)
name: Frédéric Galacteros, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Necker Enfants Malades (Children)
name: Mariane de Montalembert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Montalembert M, Voskaridou E, Oevermann L, Cannas G, Habibi A, Loko G, Joseph L, Colombatti R, Bartolucci P, Brousse V, Galacteros F; All ESCORT HU Investigators. Real-Life experience with hydroxyurea in patients with sickle cell disease: Results from the prospective ESCORT-HU cohort study. Am J Hematol. 2021 Oct 1;96(10):1223-1231. doi: 10.1002/ajh.26286. Epub 2021 Jul 23.