Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity

NCT05556382 | Unknown

• 1 other identifier: 3075
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Determination of distribution of number of γH2AX foci in each irradiated specimen (Nfoci) for each radiation dose level

  Number of foci per irradiated sample (Nfoci) for each dose level expressed as \[(number of observed γH2AX foci per selected dose level)-(number of observed γH2AX foci in control unirradiated sample)\].

  1 month

Secondary Outcomes (1)

• correlation between n° of γH2AX foci and dose levels

  1 month

Interventions

radiation of brain tissue specimen and dna damage analysis RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioblastoma Patients eligible for surgical procedure.

You may qualify if:

• 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

You may not qualify if:

• Other extra-cranial cancer
• Non GBM glioma
• Previous brain radiation therapy

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Clinical Institute

Rozzano, Milan, 20089, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh brain tissue sample witdraw during tumor surgical resection. Tissue samples will be incubated in culture medium for 24 hours and exposed to increasing single radiation dose (0, 2, 4, 6 Gy) with a linear accelerator. Specimens will be further incubated for 24 hours and subsequently fixed in formaldehyde and paraffin-embedded: γH2AX analysis will be conducted on cross-sections from the paraffin-embedded tumor material after tissue staining using confocal microscopy.

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Luisa Bellu, MD

CONTACT

+39 0282248536; luisa.bellu@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: June 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

IT (1)