Clinical trial · Observational
Surgically Induced Neurological Deficits in Glioblastomas (SIND Study)
Assessing Impact of Surgically-induced Deficits on Patient Functioning and Quality of Life (SIND Study)
- 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)
This study provides a work package for a larger programme of research developing Precision Surgery for Glioblastomas by developing individualised treatment volumes for surgery and radiotherapy. This study will recruit a cohort of patients with tumours in different brain regions and involve imaging pre- and post-operatively to outline the area of 'injury' to normal brain. The investigators will then correlate anatomical disruption with changes in measures of quality of life, visual functioning and visual fields and neuropsychology.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Maximal, safe resection of brain tumour | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group
- description
- 30 patients undergoing biopsy for brain tumour. They have the effect of the tumour but not the impact of surgery. Changes in QoL will inform the RCI measures planned
- label
- Surgery Group
- description
- The main test group. This group have been determined by their treating surgeon to undergo a resection of the tumour so will be different from the control arm by undergoing a safe, maximal resection of their tumour
- interventionNames
- Procedure: Maximal, safe resection of brain tumour
Primary outcomes (1)
- measure
- Impact of new deficit on quality of life
- timeFrame
- 5 +/- 1 weeks post surgery (delayed assessment as defined above)
- description
- Comparison of quality of life measures (using EORTC QLQ30 with BN20 module scores) for patients with and without newly developed surgically induced deficits. These are standard tools for assessing patient reported quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Have given written informed consent to participate * Assessed by a neuroscience multi disciplinary team meeting (MDT) to have a high grade glioma on imaging; * World Health Organisation Performance Scale (WHO PS 0 or 1); * Patient suitable for tumour resection where the treating neurosurgeon feels that \>90% of the enhancing tumour will be resected. Exclusion Criteria: * Pre-existing complete homonymous hemianopia or unilateral blindness or visual problems leading to patient being certified sight impaired (visual acuity of 3/60 to 6/60 with a full field of vision or visual acuity of up to 6/24 with a moderate reduction of field of vision or with a central part of vision that is cloudy or blurry). * Pre-existing severe psychiatric disease * Patients who are unsuitable for a contrast-enhanced MRI will be excluded. Such clinical problems include, but are not limited to: * MR unsafe metallic implants; * Claustrophobia; * Allergy to gadolinium contrast agent; * History of severe renal impairment.
References
Publications (0)
Data not yet available