Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients. (NCT04367779) | Clinical Trial Compass
CompletedNot Applicable
Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
France84 participantsStarted 2020-09-24
Plain-language summary
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.
Who can participate
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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 - W…
What they're measuring
1
Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy
Timeframe: At 6 months after the end of Proton Beam Therapy