Can a Child's own words improve cancer care?
NCT ID NCT07738601
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This study asks whether a simple questionnaire, called SSPedi, can capture the symptoms that children with brain or spinal cord tumors experience while on new cancer therapies. Children aged 2 to 18 who are already part of a larger French study (SACHA) will use an app to report their symptoms. Researchers will compare these reports with side effects noted by doctors to see if the child's perspective adds valuable information for better care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SSPedi questionnaire (a self-report tool for children to record their symptoms)
- What this could lead to
- If successful, this could improve how symptoms are captured in pediatric cancer trials, leading to better supportive care and more patient-centered outcomes.
- What could go wrong
- The study is observational and small (72 participants), so findings may not apply broadly. Also, children's self-reports may not always match clinician assessments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants are enrolled in PRO-SACHA at the same time as their enrollment in SACHA (two separate studies with separate enrollment). SSPedi responses (a self-report questionnaire capturing symptoms experienced by patients) are collected electronically through an online application
- Ages
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2 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 2 to 18 years * Patients aged 8 to 18 years who can read French, English, or Spanish fluently OR patients aged 6 to 7 years who can read French, English, or Spanish fluently, OR patients aged 2 to 7 years who cannot read fluently but whose parents can read French, English, or Spanish fluently * Patients included in the SACHA study before starting treatment * Patients with a pediatric tumor or leukemia who have failed treatment or relapsed and have no standard treatment options available OR patients receiving first-line treatment with no standard treatment options available (e.g., inoperable plexiform neurofibroma and MEK inhibitors, infantile fibrosarcoma and NTRK inhibitors) * Not eligible for an open early-phase clinical trial in France, or declining participation * Treated with a new innovative medicinal product and discussed at a RCCPI meeting under a granted early access authorization or compassionate use authorization issued by the ANSM, or receiving off-label use of a medicinal product already authorized in adults * Treated in one of the SFCE centers authorized to prescribe chemotherapy * The holders of parental authority have stated their non-opposition to their child's participation in the study after being informed. Minors will receive age-appropriate information adapted to their level of understanding. If the minor is emancipated, they will provide non-opposition directly * A patient who is prescribed another innovative therapy and is re-included in SACHA may be included again in PRO-SACHA Exclusion Criteria: * Patient who has already started the innovative treatment * Patients aged 8 years and older who cannot read * Patients whose clinical condition does not allow them to report symptoms themselves (i.e., non-communicative patient; judgment left to the investigator's discretion) * Patients currently enrolled in an early-phase trial * Refusal of participation by the patient or their legal representatives * Patient unable to express consent to participate in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Assistance Publique - Hôpitaux de Marseille
Marseille, France
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