Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity

NCT ID: NCT05556382

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-28
• Study Completion Date: 2023-12-31

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.

Conditions

Glioblastoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

radiation of brain tissue specimen and dna damage analysis

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Clinical Institute

Rozzano, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luisa Bellu, MD

Role: CONTACT

luisa.bellu@humanitas.it

+39 0282248536

Facility Contacts

Luisa Bellu, MD

Role: primary

luisa.bellu@humanitas.it

+39 0282248536

Other Identifiers

3075

Identifier Type: -

Identifier Source: org_study_id