To hear about similar clinical trials, please enter your email below
Trial Title:
Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity
NCT ID:
NCT05556382
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
radiation of brain tissue specimen and dna damage analysis
Description:
increasing doses of radiation on brain tissue specimen and analysis of related dna
damage.
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.
Criteria for eligibility:
Study pop:
Glioblastoma Patients eligible for surgical procedure.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Humanitas Clinical Institute
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luisa Bellu, MD
Phone:
+39 0282248536
Email:
luisa.bellu@humanitas.it
Start date:
June 28, 2022
Completion date:
December 2023
Lead sponsor:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Source:
Istituto Clinico Humanitas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05556382
