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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: Recruiting study of Glioblastoma and Glioblastoma Multiforme, sponsored by Jasper Gerritsen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time from diagnosis to death from any cause
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,015 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2029-01-01 |
What NCT06146738 shows while recruiting
NCT06146738 is an observational study that tracks outcomes without assigning an intervention. Its 1,015 participants enrollment target places it among the larger protocols in the corpus, above the 104-participant average among 199 other Glioblastoma trials with a reported enrollment target (876% higher).
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 lists 8 locations in 5 states (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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Where NCT06146738's enrollment target sits among peer trials
1,015 2nd of 199 the highest of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
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