Biomolecular Analysis for Predicting Response to Regorafenib

NCT ID: NCT05759195

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2024-12-31

Brief Summary

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The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.

Detailed Description

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Conditions

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Glioblastoma Glioblastoma, IDH-wildtype

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Biomolecular tumor analysis

NGS, IHC, methylome and other molecular studies

Group Type OTHER

Biomolecular tumor analysis

Intervention Type DIAGNOSTIC_TEST

NGS analysis, other molecular analyses on FFPE tumor tissue

Interventions

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Biomolecular tumor analysis

NGS analysis, other molecular analyses on FFPE tumor tissue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. recurrent glioblastoma after surgery and chemoradiation with temozolomide;
2. indication to treatment with regorafenib per standard of care;
3. written informed consent.

Exclusion Criteria

None.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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3458

Identifier Type: -

Identifier Source: org_study_id

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