Scientists hunt for biomarkers to personalize proton beam cancer therapy
NCT ID NCT04367779
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study enrolled 84 people with brain tumors, meningioma, or high-grade sarcoma who received proton beam therapy. Researchers analyzed tumor and blood samples to find biomarkers that might predict how well the cancer responds to treatment. The goal is to eventually help doctors choose the best therapy for each patient.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- proton beam therapy
- What this could lead to
- If successful, this could help doctors predict which patients will benefit most from proton beam therapy, personalizing cancer treatment.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find reliable biomarkers, and results may not change clinical practice soon.
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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84 people
The number who actually took part.
- Started
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Sep 2020
- Finished
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Sep 2024
- 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
Alive or Dead cancer patients with high grade sarcoma, brain tumors or meningioma Previously treated with PBT since 2016 (Retrospective cohort) or Patients to be treated with PBT (Prospective cohort)
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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: * I1 Male or female patients, all ages are eligible. * I2 Confirmed diagnosis of macroscopic tumor previously treated since 2016 (retrospective cohort) or to be treated (prospective cohort) with PBT including one of the following tumor types:Cohort A : high grade sarcoma ; Cohort B: brain tumors; Cohort C: meningioma. * I3 Presence of at least one measurable lesion before PBT initiation. Post operative situation is possible providing a measurable macroscopic residue, non candidate to a new surgery before PBT. * I4 Availability of archival representative formalin-fixed, paraffin-embedded (FFPE) and/or frozen tumor sample, with the corresponding hematoxylin and eosin stained slide and a pathological report, meeting the following quality/quantity control (QC) criteria confirmed by a central pathological review: (this sample will be also used to confirm pathological diagnosis ) : at least 20% of tumor cells and a surface area \> 5mm2 with \> 90μm of depth. * I5. Performance status before PBT: Lansky Play score for pediatric patients \< 12 years of age ≥ 70%; Karnofsky performance status for pediatric patients ≥ 12 years of age ≥ 70%; PS ECOG for adult patients: 0, 1 or 2. * I6. For prospective cohort : Life-expectancy before PBT \> 2 years . * I7. For prospective cohort : Women of child-bearing potential and men must agree to use (must have used for retrospective cohort) adequate contraception during all the radiotherapy procedure * I8. For alive patients - Written informed consent from patient, parents if applicable/legal representative, before any study-specific screening procedures, and willingness to comply to study visits and procedures. Exclusion Criteria: * E1. Patients previously treated with radiotherapy in the same site (re-irradiation), either with protons or photons * E2. Pregnant or breast-feeding patients at time of PBT initiation.
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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.
Contacts and locations
Locations
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Centre Antoine Lacassagne
Nice, 06189, France
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Centre Léon Bérard
Lyon, 69008, France
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Other studies related to the condition(s) this trial covers.
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