Clinical trial Recruiting at 1 site Observational Ages 0 to 25

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.

More Pediatric Cancer trials

Quick facts

Study typeObservational
Ages0 Years to 25 Years
SexAll
Enrollment1600 (estimated)
SponsorUniversitaire Ziekenhuizen KU Leuven
Academic / other
Locations6 sites (Antwerp and 5 other locations)
StatusRecruiting
StartedJuly 2026
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedJuly 27, 2026
Trial IDNCT07727694 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.