Status:
RECRUITING
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
Lead Sponsor:
Jasper Gerritsen
Collaborating Sponsors:
Haaglanden Medical Centre
Universitaire Ziekenhuizen KU Leuven
Conditions:
Glioblastoma
Glioblastoma, IDH-wildtype
Eligibility:
All Genders
18-90 years
Brief 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)...
Detailed Description
Trial design This is an international, multicenter, prospective, observational, 2-arm cohort study (registration: clinicaltrials.gov ID number TBA). Eligible patients are treated with either resection...
Eligibility Criteria
Inclusion
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Exclusion
- Tumors of the cerebellum, brainstem or midline
- Medical reasons precluding MRI (e.g. pacemaker)
- Inability to give written informed consent
- Secondary high-grade glioma due to malignant transformation from low-grade glioma
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT06146725
Start Date
January 1 2023
End Date
January 1 2029
Last Update
November 27 2023
Active Locations (8)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
University Hospital Leuven
Leuven, Belgium
4
Technical University Munich
Munich, Bavaria, Germany, 74076