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NCT06146725 · ClinicalTrials.gov registry record
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
A clinical trial of Glioblastoma and Glioblastoma Multiforme, sponsored by Jasper Gerritsen.
- Recruiting
- Registry status
- 564
- Enrollment target
- 8
- Study locations
NCT06146725: Recruiting study of Glioblastoma and Glioblastoma Multiforme, sponsored by Jasper Gerritsen.
NCT06146725 is a study of Glioblastoma and Glioblastoma Multiforme that is actively recruiting participants, run by Jasper Gerritsen. The registered enrollment target is 564 participants, above the 106-participant average among 199 other Glioblastoma trials with a reported enrollment target (432% higher). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06146725, a study of Glioblastoma and Glioblastoma Multiforme, is actively recruiting participants, sponsored by Jasper Gerritsen.
- RECRUITING
- Registry status
- 564 participants
- Enrollment target
- 8
- Study locations
Study Summary
There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). 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
- PROCEDURE Tumor biopsy
- PROCEDURE Tumor resection
Study Locations (8)
Other
- University Hospital Leuven - Leuven
- University Hospital Heidelberg - Heidelberg
- Haaglanden Medical Center - The Hague
- Inselspital Universitätsspital Bern - Bern
California
- University of California, San Francisco - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
Bavaria
- Technical University Munich - Munich
South Holland
- Erasmus Medical Center - Rotterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 564 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2029-01-01 |
What NCT06146725 shows while recruiting
NCT06146725 is an observational study that tracks outcomes without assigning an intervention. The registered 564 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 199 other Glioblastoma trials with a reported enrollment target (432% higher).
The record links to 5 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Tumor biopsy is the first listed.
NCT06146725 lists 8 locations in 5 states (Other, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06146725 about?
NCT06146725 is a clinical study titled "The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)". There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationa...
What is the current status of trial NCT06146725?
This trial is currently recruiting. The enrollment target is 564 participants. The study started on 2023-01-01. Estimated completion is 2029-01-01.
What conditions does trial NCT06146725 study?
This clinical trial studies the following conditions: Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme of Brain, Glioblastoma Multiforme, Adult.
What interventions are being tested in trial NCT06146725?
The interventions under investigation include: Tumor biopsy (PROCEDURE), Tumor resection (PROCEDURE).
Who is sponsoring clinical trial NCT06146725?
This trial is sponsored by Jasper Gerritsen, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06146725 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 NCT06146725's enrollment target sits among peer trials
564 8th of 199 higher than 192 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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