The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202) (NCT06146725)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, San Francisco — San Francisco, California
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
- Tumor resection (PROCEDURE)
- Tumor biopsy (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- University of California, San Francisco — San Francisco, California
- Massachusetts General Hospital — Boston, Massachusetts
- University Hospital Leuven — Leuven,
- Technical University Munich — Munich, Bavaria
- University Hospital Heidelberg — Heidelberg,
- Erasmus Medical Center — Rotterdam, South Holland
- Haaglanden Medical Center — The Hague,
- Inselspital Universitätsspital Bern — Bern,
📞 Contact the Study Coordinator
Phone: +31107036130
Email: j.gerritsen@erasmusmc.nl
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.