Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity

Glioblastoma Clinical Trial

— GEHIRN  

Official title:

Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity (GEHIRN): Preclinical Observational Study on Ex-vivo Surgical Specimens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556382
• Other study ID #: 3075
• Status: Recruiting
• Start date: June 28, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Istituto Clinico Humanitas
• Contact: Luisa Bellu, MD
• Phone: +39 0282248536
• Email: luisa.bellu[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Radiation:
• radiation of brain tissue specimen and dna damage analysis
increasing doses of radiation on brain tissue specimen and analysis of related dna damage.

Locations

Country	Name	City	State
Italy	Humanitas Clinical Institute	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of distribution of number of ?H2AX foci in each irradiated specimen (Nfoci) for each radiation dose level	Number of foci per irradiated sample (Nfoci) for each dose level expressed as [(number of observed ?H2AX foci per selected dose level)-(number of observed ?H2AX foci in control unirradiated sample)].	1 month
Secondary	correlation between n° of ?H2AX foci and dose levels	this correlation will be described by the slope for each sample Nfoci at increasing dose levels	1 month