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NCT06146738 · ClinicalTrials.gov registry record

The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)

A clinical trial of Glioblastoma and Glioblastoma Multiforme, sponsored by Jasper Gerritsen.

Recruiting
Registry status
1,015
Enrollment target
8
Study locations

NCT06146738 is a study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Jasper Gerritsen. The registered enrollment target is 1,015 participants, above the 104-participant average among 199 other Glioblastoma trials with a reported enrollment target (876% higher). The trial reports 8 study locations across 5 states.

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The verdict

NCT06146738, a study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Jasper Gerritsen.

RECRUITING
Registry status
1,015 participants
Enrollment target
8
Study locations

Study Summary

There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

Conditions Studied

Glioblastoma Glioblastoma Multiforme Glioblastoma, IDH-wildtype Glioblastoma Multiforme, Adult

Interventions

  • BEHAVIORAL Palliative Care
  • PROCEDURE Tumor biopsy
  • PROCEDURE Tumor resection

Study Locations (8)

Other

  • University Hospital Leuven - Leuven
  • University Hospital Heidelberg - Heidelberg
  • Inselspital Universitätsspital Bern - Bern

South Holland

  • Erasmus Medical Center - Rotterdam
  • Haaglanden Medical Centre - The Hague

California

  • University of California, San Francisco - San Francisco

Massachusetts

  • Massachusetts General Hospital - Boston

Bavaria

  • Technical University Munich - Munich

Trial Details

FieldValue
Enrollment Target 1,015 participants
Start Date 2023-01-01
Est. Completion 2029-01-01

Sponsor

Jasper Gerritsen

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06146738

The ClinicalTrials.gov registry entry for NCT06146738 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,015 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 104-participant average among 199 other Glioblastoma trials with a reported enrollment target (876% higher). The listed sponsor is Jasper Gerritsen, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Palliative Care is the first listed.

NCT06146738 reports 8 study locations spanning 5 distinct geographic areas - top geographies include Other, South Holland, California.

Frequently Asked Questions

What is clinical trial NCT06146738 about?

NCT06146738 is a clinical study titled "The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)". There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This stud...

What is the current status of trial NCT06146738?

This trial is currently recruiting. The enrollment target is 1,015 participants. The study started on 2023-01-01. Estimated completion is 2029-01-01.

What conditions does trial NCT06146738 study?

This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult.

What interventions are being tested in trial NCT06146738?

The interventions under investigation include: Palliative Care (BEHAVIORAL), Tumor biopsy (PROCEDURE), Tumor resection (PROCEDURE).

Who is sponsoring clinical trial NCT06146738?

This trial is sponsored by Jasper Gerritsen, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06146738 being conducted?

This trial has 8 study locations across California, Massachusetts, Bavaria, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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