Identifying biomarkers for response to proton beam therapy in cancer patients
PROTONBIOMARKS - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients: A Genomic, Epigenetic, and Immunological Analysis
This study is trying to find specific markers in cancer patients that can help predict how well they will respond to Proton Beam Therapy for different types of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Drugs / interventions | Radiation |
| Locations | 2 sites (Lyon and 1 other locations) |
| Trial ID | NCT04367779 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to identify biomarkers that predict how patients respond to Proton Beam Therapy (PBT) for various cancers, including brain tumors, meningiomas, and high-grade sarcomas. It involves both retrospective and prospective enrollment of patients, collecting clinical data, tumor samples, and blood samples from living participants. The study leverages expertise from multiple centers to optimize treatment strategies and improve patient outcomes based on the identified biomarkers.
Who should consider this trial
Good fit: Ideal candidates include male and female patients of all ages with a confirmed diagnosis of specific tumors treated or to be treated with proton beam therapy.
Not a fit: Patients without measurable lesions or those whose tumors are not among the specified types may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment plans for patients undergoing proton beam therapy.
How similar studies have performed: Previous studies have shown promising results in identifying biomarkers related to treatment response, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Lyon and 1 other locations
- Centre Léon Bérard — Lyon, France (Recruiting)
- Centre Antoine Lacassagne — Nice, France (Recruiting)
Study contacts
- Principal investigator: Claude Line — Centre Leon Berard
- Study coordinator: Gwenaële Garin
- Email: gwenaelle.garin@lyon.unicancer.fr
- Phone: + 33 (0)4 78 78 28 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.