Clinical trial · Observational
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma, IDH-wildtype | Glioblastoma, IDH-Wildtype | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme, Adult | Adult Glioblastoma | ALIAS | 0.90 |
| Glioblastoma Multiforme of Brain | Brain Glioblastoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor biopsy | Procedure | — | UNRESOLVED |
| Tumor resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Tumor resection
- description
- Tumor resection
- interventionNames
- Procedure: Tumor resection
- label
- Tumor biopsy
- description
- Tumor biopsy
- interventionNames
- Procedure: Tumor biopsy
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Up to 5 years postoperatively
- description
- Time from diagnosis to death from any cause
- measure
- Adjuvant treatment with chemotherapy and radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon 3. Written informed consent Exclusion Criteria: 1. Tumors of the cerebellum, brainstem or midline 2. Medical reasons precluding MRI (e.g. pacemaker) 3. Inability to give written informed consent 4. Secondary high-grade glioma due to malignant transformation from low-grade glioma 5. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin
References
Publications (1)
- DERIVEDGerritsen JKW, Young JS, Krieg SM, Jungk C, Ille S, Schucht P, Nahed BV, Broekman MLD, Berger M, De Vleeschouwer S, Vincent AJPE. Resection versus biopsy in patients with glioblastoma (RESBIOP study): study protocol for an international multicentre prospective cohort study (ENCRAM 2202). BMJ Open. 2024 Sep 10;14(9):e081689. doi: 10.1136/bmjopen-2023-081689. PMID 39260848