NCT04367779Completed
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
This trial is a paucicentric, clinico-biological cohort study with retrospective and prospective enrollment, aiming to identify biomarkers predictive of response to Proton Beam Therapy (PBT) in cancer patients (high grade sarcoma, brain tumors and meningioma). This study include collection of clinical data, of tumor samples (collected during standard of care) and a blood sample for alive patients.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 84 (actual)
- First submitted
- 24 Apr 2020
- Start date
- Sept 2020
- Primary completion date
- Sept 2024
- Lead sponsor
- Centre Leon Berard
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT04367779
What you commit to
- Study type: Observational
- Participants enrolled: 84
- From Sept 2020 to the primary completion date, Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- E1. Patients previously treated with radiotherapy in the same site (re-irradiation), either with protons or photons
Other
- E2. Pregnant or breast-feeding patients at time of PBT initiation.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.