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Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
Sponsor: Universitaire Ziekenhuizen KU Leuven
Summary
It involves collecting safety and efficacy data, under the actual conditions of use of off label and compassionate use medicines in children and adolescents approved in humans before 2007, using a validated tool (Ennov EDC) and relying on the network recognised pediatric hemato-oncology centers in Belgium and responsible for the organization of Pediatric National tumor boards which discuss each case of relapse in order to define the best therapeutic options.
Key Details
Gender
All
Age Range
0 Years - 25 Years
Study Type
OBSERVATIONAL
Enrollment
1600
Start Date
2026-07
Completion Date
2030-12-31
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
data collection
In particular, the patient's demographic data, medical history, previous and concomitant treatments, data on the treatment of interest (legal framework, compassionate use/ off-label), dosage, start date, etc.), clinical data will be collected. biological (including molecular profiling of the tumor if available) and radiological follow-up, information on adverse effects.
Locations (6)
University Hospital Antwerp
Antwerp, Belgium
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium
University Hospital Gent
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
CHC Montlégia
Liège, Belgium