Access to Innovative Cancer Treatments for Children and Young People in Belgium
Official title: Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
Run by Universitaire Ziekenhuizen KU Leuven · NCT07727694 · Data updated 2026-11-12
This observational study collects safety and effectiveness data on off‑label and compassionate cancer medicines used in kids and young adults up to age 25 in Belgium.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 25 Years |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 6 sites (Antwerp and 5 other locations) |
| Status | Recruiting |
| Started | July 2026 |
| Main results expected | December 31, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07727694 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients ≤25 with pediatric solid tumors or leukemia receiving off‑label or compassionate-use cancer medicines first approved in adults after 2007, discussed at MDTs, and not enrolled in another therapeutic trial.
✕Probably not a fit
Patients not receiving off‑label or compassionate-use therapy, or those whose situations are not discussed in MDTs or who do not meet consent requirements, may not benefit from this data collection.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will gather real-world safety and efficacy information from pediatric cancer patients treated with off‑label or compassionate-use drugs approved for adults after 2007. Data collection uses the Ennov EDC system and involves recognized pediatric hemato-oncology centers that coordinate through national tumor boards. The study aims to map use across the country and inform best therapeutic options for relapsed cases. Participation requires MDT discussion and consent where required by national rules. No new experimental treatments are being tested within a traditional trial framework.
Why it matters
Potential benefit: If successful, the study could improve understanding of off‑label and compassionate-use therapies and help guide safer, more effective options for children and young adults with cancer.
How similar studies have gone: Previous observational data collections have shown value in mapping real-world use of off‑label oncology medicines, though approaches vary by country.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University Hospital Leuven
Leuven, Belgium Recruiting -
University Hospital Antwerp
Antwerp, Belgium Not yet recruiting -
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Belgium Not yet recruiting -
Cliniques Universitaires Saint-Luc
Brussels, Belgium Not yet recruiting -
University Hospital Gent
Ghent, Belgium Not yet recruiting -
CHC Montlégia
Liège, Belgium Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.