Surgically Induced Neurological Deficits in Glioblastomas (SIND Study) (SIND)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04007185|
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : July 19, 2021
|Condition or disease||Intervention/treatment|
|Glioblastoma||Procedure: Maximal, safe resection of brain tumour|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Assessing Impact of Surgically-induced Deficits on Patient Functioning and Quality of Life (SIND Study)|
|Actual Study Start Date :||May 15, 2021|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||December 2024|
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
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
Procedure: Maximal, safe resection of brain tumour
Standard surgical resection as part of routine care
- Impact of new deficit on quality of life [ Time Frame: 5 +/- 1 weeks post surgery (delayed assessment as defined above) ]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
- Anatomical disruption [ Time Frame: Within 72 hours of surgery (early assessment as defined above) ]
Anatomical disruption will be achieved by:
- Voxel-based lesion-symptom mapping;
- White matter tracts disrupted (from DTI data).
- Recovery of visual deficits [ Time Frame: 5 +/- 1 weeks post surgery (delayed assessment as defined above) ]Investigate recovery of surgically-induced visual deficits by comparing visual function between early assessment and delayed assessment (before starting radiotherapy). Definitions of visual deficits have been clearly defined in the protocol. To confirm they are - Visual deterioration will be defined as either deterioration in visual acuity (reduction in LogMAR >0.2), or an increase in visual field loss. Deterioration in the NEI-VFQ25 will be determined by published minimal important clinical differences.
- Recovery of cognitive deficits using OCS-Bridge tool [ Time Frame: Within 72 hours of surgery (early assessment as defined above) ]Investigate recovery of surgically-induced cognitive deficits (measured using the OCS-Bridge tool) by comparing cognitive function between early assessment and delayed assessment. Definitions of cognitive deficits are defined as >2 standard deviations from established data from normal patients.
- Quantifying white matter tract disruption [ Time Frame: 5 +/- 1 weeks post surgery (delayed assessment as defined above) ]Quantifying white matter tract disruption by correlating DTI metrics with development of new visual deficits. This will be made by comparing visual field deficits (defined as the angle of field loss at delayed assessment compared to baseline) with extent of white matter disruption on DTI (defined from changes in DTI from baseline to early assessment).
- Impact of deficits on overall survival [ Time Frame: Developing a deficit/not developing deficit will be classified at 6 weeks of surgery (pre-RT). Overall survival figures will be followed until the death of the patient or six months from the last patient undergoing their post-RT assessment. ]Explore impact of new visual and cognitive deficit has on overall survival (defined as date of death from any cause, measured in weeks, assessed up to 3 years post-operatively), compared to patients that don't develop these deficits
- Cognitive reserve [ Time Frame: 5 +/- 1 weeks post surgery (delayed assessment as defined above) ]Patients will be divided at baseline into three categories of cognitive reserve using the CRq questionnaire that estimates high, medium and low cognitive reserve. We will correlate these categories with changes in cognitive assessments using the OCS-Bridge tool.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007185
|Contact: Stephen J Price, PhD FRCSfirstname.lastname@example.org|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Victoria Hughes, PhD 01480 830541 email@example.com|
|Principal Investigator:||Stephen J Price, PhD FRCS||University of Cambridge|