Pediatric Cancer(SACHA)NCT07727694
Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
An observational study of Pediatric Cancer, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- data collection
- How many people
- 1,600 participants
- Where
- 6 sitesBelgium
- Study dates
- Jul 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Any child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of compassionate use or outside marketing authorization, in one of the centers of the pediatric hemato-oncology centers in Belgium
Who may be able to join
- 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
Who cannot join
- Patient receiving the drug within a clinical trial.
- Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Belgium6 sites, 6 recruiting
- Not yet recruiting
University Hospital Antwerp
Antwerp, 2650
Toon Van Genechten, MD, +32 3 821 58 58, toon.vangenechten@uza.be
- Not yet recruiting
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, 1020
Pierluigi Calò, MD, +32 2 477 26 78, Pierluigi.CALO@hubruxelles.be
- Not yet recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
An Van Damme, MD, +32 2 764 23 50
- Not yet recruiting
University Hospital Gent
Ghent, 9000
Bram De Wilde, MD, +32 9 332 48 12, bram.dewilde@uzgent.be
- Recruiting
University Hospital Leuven
Leuven, 3000
Sandra Jacobs, MD, +32 16 34 39 72, sandra2.jacobs@uzleuven.be
- Not yet recruiting
CHC Montlégia
Liège, 4000
Christophe Chantrain, MD, +32 4 355 50 20, christophe.chantrain@chc.be
About this study
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.
Read the 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.
- Conditions
- Pediatric Cancer
- Being tested
- data collection
- Keywords
- observational, data collection, childhood cancer, pediatric cancer, off label medication, CU medication
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients in therapeutic failure or relapse | Any child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of a compassionate use or outside marketing authorization, in one of the centers of the Belgian pediatric hemato-oncology centers Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect safety data
From patients receiving innovative molecules outside a clinical trial (targeted therapies, immunotherapies or chemotherapies off label or compasionate use approved in adults as of 2007), safety data will be collected. Adverse events will be collected through the CTCAE version N°5.
Measured: through study completion, an average of 1 year
Collect activity data
From patients receiving innovative molecules outside a clinical trial (targeted therapies, immunotherapies or chemotherapies off label or compasionate use approved in adults as of 2007), the response to the treatment (complete response, partial response, stable disease, progression) will be collected.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJul 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727694
- Sponsor's protocol ID
- S67492
- Acronym
- (SACHA)
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Securing Access to Innovative Molecules in Oncology and Hematology for Children, Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07727694
- Acronym / sponsor ID
- (SACHA) / S67492
- Conditions
- Pediatric Cancer
- Keywords
- observational, data collection, childhood cancer, pediatric cancer, off label medication, CU medication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in therapeutic failure or relapse | – | Other: data collectionAny child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of a compassionate use or outside marketing authorization, in one of the centers of the Belgian pediatric hemato-oncology centers |
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Any child, adolescent or young adult, treated for a pediatric tumor or leukemia, in therapeutic failure or relapse without standard treatment option, not eligible / refusal of inclusion in a clinical study open on the territory and treated with an innovative drug within the framework of compassionate use or outside marketing authorization, in one of the centers of the pediatric hemato-oncology centers in Belgium
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient receiving the drug within a clinical trial.
- Oral refusal to participate to the study, by the patient or his/her parents/legal representatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectionIn 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. | Other | Patients in therapeutic failure or relapse |
Primary outcome
Collect safety data
Time frame: through study completion, an average of 1 year
From patients receiving innovative molecules outside a clinical trial (targeted therapies, immunotherapies or chemotherapies off label or compasionate use approved in adults as of 2007), safety data will be collected. Adverse events will be collected through the CTCAE version N°5.
Collect activity data
Time frame: through study completion, an average of 1 year
From patients receiving innovative molecules outside a clinical trial (targeted therapies, immunotherapies or chemotherapies off label or compasionate use approved in adults as of 2007), the response to the treatment (complete response, partial response, stable disease, progression) will be collected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Belgium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer, run by Universitaire Ziekenhuizen KU Leuven at 6 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect safety data (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.