Surgically Induced Neurological Deficits in Glioblastomas (SIND Study)

NCT04007185 | Active Not Recruiting

• 2 other identifiers: SIND-2018CDF-2018-11-ST2-003
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

quality of life; cognitive function; visual function; surgery

Outcome Measures

Primary Outcomes (1)

• Impact of new deficit on quality of life

  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

  5 +/- 1 weeks post surgery (delayed assessment as defined above)

Secondary Outcomes (5)

• Anatomical disruption

  Within 72 hours of surgery (early assessment as defined above)

• Recovery of visual deficits

  5 +/- 1 weeks post surgery (delayed assessment as defined above)

• Recovery of cognitive deficits using OCS-Bridge tool

  Within 72 hours of surgery (early assessment as defined above)

• Quantifying white matter tract disruption

  5 +/- 1 weeks post surgery (delayed assessment as defined above)

• Impact of deficits on overall survival

  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.

Other Outcomes (1)

• Cognitive reserve

  5 +/- 1 weeks post surgery (delayed assessment as defined above)

Study Arms (2)

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

Interventions

Maximal, safe resection of brain tumour PROCEDURE

Standard surgical resection as part of routine care

Surgery Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glioblastoma patients presenting to a single neurosciences MDT

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Stephen Price

Cambridge, CB2 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour samples will be retained as part of routine care in our Tumour Bank

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Stephen J Price, PhD FRCS

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NIHR Career Development Fellow and Hon. Consultant Neurosurgeon

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: July 5, 2019
• Study Start: May 15, 2021
• Primary Completion: July 29, 2024
• Study Completion: December 31, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

GB (1)