Biomolecular Analysis for Predicting Response to Regorafenib

Not Applicable

Completed

• Conditions: Glioblastoma; Glioblastoma, IDH-wildtype
• Interventions: Diagnostic Test: Biomolecular tumor analysis

• Registration Number: NCT05759195
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Not available

Study Timeline

• Study Start: 2021-01-07
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biomolecular tumor analysis	Biomolecular tumor analysis	NGS, IHC, methylome and other molecular studies

Primary Outcome Measures

Name	Time	Method
Overall survival	through study completion, an average of 3 years	Interval between tumor diagnosis and death or end of follow-up

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy