Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data collection.
- Who it may be relevant to
- Registry conditions: Pediatric Cancer. Basic parameters: 0 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
The objective is to aim for completeness throughout the national territory. This is why this project will be carried out in close collaboration with all recognised pediatric hemato-oncology centers in Belgium.
Interventions
- Other 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.
Primary outcome measures
- Collect safety data [Time frame: through study completion, an average of 1 year]
- Collect activity data [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Age ≤ 25 at the time of inclusion in the study
- Patient with a pediatric malignancy (solid tumor or leukemia), or other related condition
- Patient not currently enrolled on any other trial for ongoing therapeutic purposes
- Patient treated with compassionate use of experimental drugs or off-label administration use of anti-cancer medicines first approved in adults after 2007 in Europe
- Patient discussed in a Pediatric multidisciplinary tumor boards (MDTB) to validate the inclusion in the SACHA study
- Consent to participate by the patient or his/her legal representatives in the study if required by ta particular national jurisdiction
Exclusion criteria
- Patient receiving the drug within a clinical trial.
- Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Belgium · 6 centers
- University Hospital Antwerp — Antwerp
- Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) — Brussels
- Cliniques Universitaires Saint-Luc — Brussels
- University Hospital Gent — Ghent
- University Hospital Leuven — Leuven
- CHC Montlégia — Liège
Identifiers
NCT: NCT07727694 · S67492