Glioblastoma Evaluation for Heterogeneity In RadioseNsiti... | NCT05556382

Studies
Glioblastoma Evaluation for Heterogeneity In RadioseNsitivity

NCT05556382

Sponsor

Istituto Clinico Humanitas

Status

Unknown status

Last Update Posted

Oct 6, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Glioblastoma

Interventions

radiation of brain tissue specimen and dna damage analysis

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2022Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Sep 22, 2022

First Submission Date that Met QC Criteria

Sep 22, 2022

First Posted Date

Sep 27, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2022

Last Update Posted Date

Oct 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiation of brain tissue specimen and dna damage analysis	Radiation	increasing doses of radiation on brain tissue specimen and analysis of related dna damage.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
correlation between n° of γH2AX foci and dose levels	this correlation will be described by the slope for each sample Nfoci at increasing dose levels	1 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Glioblastoma Patients eligible for surgical procedure.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luisa Bellu, MD	Contact	+39 0282248536		luisa.bellu@humanitas.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Humanitas Clinical Institute	Recruiting	Rozzano	Milan	20089	Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.