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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 : Not yet recruiting
First Posted : July 5, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Stephen J Price, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Glioblastoma Procedure: Maximal, safe resection of brain tumour

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Impact of Surgically-induced Deficits on Patient Functioning and Quality of Life (SIND Study)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control group
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
Surgery Group
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Anatomical disruption [ Time Frame: Within 72 hours of surgery (early assessment as defined above) ]

    Anatomical disruption will be achieved by:

    1. Voxel-based lesion-symptom mapping;
    2. White matter tracts disrupted (from DTI data).

  2. 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.

  3. 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.

  4. 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).

  5. 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


Other Outcome Measures:
  1. 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
Tumour samples will be retained as part of routine care in our Tumour Bank


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Glioblastoma patients presenting to a single neurosciences MDT
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Stephen J Price, PhD FRCS 01223746455 sjp58@cam.ac.uk

Locations
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United Kingdom
Stephen Price
Cambridge, United Kingdom, CB2 0QQ
Contact: Victoria Hughes, PhD    01480 830541    victoria.hughes1@nhs.net   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Stephen J Price, PhD FRCS University of Cambridge

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Responsible Party: Stephen J Price, NIHR Career Development Fellow and Hon. Consultant Neurosurgeon, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04007185    
Other Study ID Numbers: SIND-2018
CDF-2018-11-ST2-003 ( Other Grant/Funding Number: National Institute of Health Research (NIHR) )
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is being explored as part of a United Kingdom's Cancer Research UK initiative

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen J Price, Cambridge University Hospitals NHS Foundation Trust:
quality of life
cognitive function
visual function
surgery
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue