Glioblastoma
Conditions
Brief summary
This is an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular the investigators will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.
Detailed description
Standard of care for newly diagnosed glioblastoma (GBM) patients consists of surgical resection followed by radiotherapy with concurrent and adjuvant Temozolomide chemotherapy. Despite these treatments, the prognosis remains poor. Nevertheless, preliminary data on GBM patients show variable outcomes related to a different treatment response, that could be related to the GBM intrinsic heterogeneity, but also to a different patient sensitivity to radiation therapy. The assessment of this individual radio-sensitivity may provide valuable data to define more tailored treatment schedules, that could potentially be more effective. Published studies on small cohort of patients show that a possible system to investigate the tumor radiation sensitivity, is to monitor the cellular DNA damage after tissue irradiation, that correlates with the survival fraction of in vitro tumor cells; the DNA damage could be identified through the quantification of Phosphorylated histone H2AX nuclear foci that correlate with the unrepaired DNA double strand breaks (DSBs). Based on this background, The investigators designed an observational study on GBM surgical samples to investigate if increasing doses of radiation therapy could improve the radiation response; and in particular they will assess if there is a correlation between the number of the phosphorylated H2AX nuclear foci and the different dose level of radiation therapy.
Interventions
RADIATIONradiation of brain tissue specimen and dna damage analysis
increasing doses of radiation on brain tissue specimen and analysis of related dna damage.
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged \>18 years * Patients eligible for diagnostic or therapeutic surgical procedure * Written informed consent * Histopathologically confirmed newly diagnosed glioblastoma according to WHO 2021 * Availability of fresh tissue samples
Exclusion criteria
* Other extra-cranial cancer * Non GBM glioma * Previous brain radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of distribution of number of γH2AX foci in each irradiated specimen (Nfoci) for each radiation dose level | 1 month | Number of foci per irradiated sample (Nfoci) for each dose level expressed as \[(number of observed γH2AX foci per selected dose level)-(number of observed γH2AX foci in control unirradiated sample)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation between n° of γH2AX foci and dose levels | 1 month | this correlation will be described by the slope for each sample Nfoci at increasing dose levels |
Countries
Italy
Contacts
Primary ContactLuisa Bellu, MD
Outcome results
None listed