Sarcoma Clinical Trial
— PROTONBIOMARKSOfficial title:
PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis
NCT number | NCT04367779 |
Other study ID # | ET19-284 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 24, 2020 |
Est. completion date | June 2024 |
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 | Recruiting |
Enrollment | 100 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon | |
France | Centre Antoine Lacassagne | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify predictive biomarkers for local response at 6 months after the end of Proton Beam Therapy | Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) | At 6 months after the end of Proton Beam Therapy | |
Secondary | To identify predictive biomarkers for clinical outcomes | Correlation between local tumor response according to RECIST 1.1 criteria and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) | At 12 months and at 24 months after the end of Proton Beam Therapy | |
Secondary | To identify predictive biomarkers for clinical outcomes | Correlation between progression free survival and expression of biomarkers expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) | From the start of Proton Beam Therapy until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | |
Secondary | To identify predictive biomarkers for clinical outcomes | Correlation between overall survival and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) | From the start of Proton Beam Therapy until the date of death from any cause, assessed up to 48 months | |
Secondary | To identify predictive biomarkers for clinical outcomes | Correlation between radiation related toxicity (only Adverse Event (AE) Grade =3) according to NCI-CTCAE V5.0. and expression of biomarkers defined by using different techniques (HTG, WES, RNAseq, IHC) | From the start of Proton Beam Therapy until at least 24 months after the end of Proton Beam Therapy |
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