NCT05759195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

February 23, 2023

Last Update Submit

March 11, 2025

Conditions

GlioblastomaGlioblastoma, IDH-wildtype

Keywords

regorafenibNGSpredictive biomarker

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Interval between tumor diagnosis and death or end of follow-up

    through study completion, an average of 3 years

Study Arms (1)

Biomolecular tumor analysis

OTHER

NGS, IHC, methylome and other molecular studies

Diagnostic Test: Biomolecular tumor analysis

Interventions

Biomolecular tumor analysisDIAGNOSTIC_TEST

NGS analysis, other molecular analyses on FFPE tumor tissue

Biomolecular tumor analysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 8, 2023

Study Start

January 7, 2021

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)