Malignant solid tumors treated with radiotherapy
Conditions
Interventions
Group 1: Primary Objectives:
• Determination of the mutation status in HR-relevant genes in patients who have received proton therapy at the WPE. Relevant genes: BRCA1, BRCA2, RAD51, RAD51B, RAD51C
Sponsors
Westdeutsches Protonentherapiezentrum Essen (WPE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented diagnosis of a tumor disease, initially focusing on patients with medulloblastoma treated with proton radiotherapy at WPE. - Treatment with proton radiotherapy at the West German Proton Therapy Centre Essen (WPE) as part of routine clinical care. - Availability of informed consent for participation in the ProReg or KiProReg registry. - Documentation of patient data in the WPE registries ProReg or KiProReg since the start of the registries in 2012 or 2013. - Availability of relevant clinical and treatment data, including patient characteristics, tumor entity, proton radiotherapy information, and data on acute and late side effects. - Availability of follow-up data, particularly overall survival and/or progression-free survival. - Availability of information on the mutation status or functional impairment of homologous recombination-related genes or related DNA repair pathways, documented in - histopathological reports, molecular pathology reports, or other medical reports. For the planned study extension: patients with any tumor entity treated with proton radiotherapy at WPE, for whom mutations in HR-associated genes or reduced HR activity are documented. - For the photon radiotherapy comparison cohort: availability of fully anonymized, publicly accessible clinical and molecular data from TCGA, PBTA, or comparable databases, including information on photon radiotherapy, tumor entity, HR-associated gene status, and clinical outcome, where available.
Exclusion criteria
Exclusion criteria: - No documented proton radiotherapy treatment at WPE for the proton therapy cohort. - No available informed consent for participation in ProReg or KiProReg for patients from the WPE registries. - Missing or insufficient documentation of the tumor entity. - Missing or insufficient clinical follow-up data preventing assessment of overall survival, progression-free survival, or side effects. -For publicly available comparison datasets: datasets will be excluded if they lack sufficient information on photon radiotherapy, HR-associated gene status, or relevant clinical endpoints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the period from initial diagnosis until death or loss to follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: • Long-term side effects induced by proton therapy, based on clinically documented late side effects. • Progression-free survival. | — |
Countries
Germany
Contacts
Public ContactBeate Timmermann
Westdeutsches Protonentherapiezentrum Essen (WPE)
Outcome results
None listed