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The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
NCT06146725 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06146725
The ClinicalTrials.gov registry entry for NCT06146725 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 564 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jasper Gerritsen, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06146725 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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 Multiforme of Brain, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06146725?
The interventions under investigation include: Tumor biopsy (PROCEDURE), Tumor resection (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06146725?
This trial is sponsored by Jasper Gerritsen, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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