Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04463979
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2020-07-02
Brief Title:
Perioperative Evaluation of Cerebellar Tumors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Perioperative Evaluation of Cerebellar Tumors Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective cohort study to evaluate the impact of cerebellar functional topography on perioperative outcomes related to cognition and motor ataxia in patients with cerebellar tumors
Detailed Description:
Purpose of the Study This is a prospective cohort study to evaluate the impact of cerebellar functional topography on perioperative outcomes related to cognition and motor ataxia in patients with cerebellar tumors
Primary Aim The primary aim of this study is to determine if patients with a cerebellar tumor are more likely to test positive for cerebellar cognitive affective syndrome than patients with non-cerebellar tumors This information will be used to improve perioperative assessment in patients with tumors of the cerebellum
Secondary Aim To determine the impact of tumor location and cerebellar functional topography on perioperative outcomes determined by standard of care neurological evaluation and brain images in patients undergoing resection of cerebellar tumors This information will be used to improve perioperative assessment in patients with tumors of the cerebellum
Study Interventions Thirty-three adult 18 years of age patients with primary cerebellar brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery for tumor resection and 33 adult patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection will be included in this study The non-cerebellar brain tumor control group will be included for comparison Participants in this study will undergo surgical resection of their cerebellar or brain tumor as per standard of care as well as clinical and radiographic assessment including neurological physical examination including Karnofsky Performance Scale KPS if conducted per Standard of Care and magnetic resonance imaging MRI with or without diffusion tensor imaging DTItractography prior to immediately after at one-month 6-month and 1-year follow-up status post-surgical resection These data will also be collected at 18-month 60 days and 24-month 60 days visits post-surgery if regular office visits with the neurosurgeon are scheduled at these two time points Only at baseline the following will be conducted Brief Ataxia Rating Scale BARS assessment score Cerebellar Cognitive Affective Scale CCASSchmahmann syndrome scale score Montreal Cognitive Assessment MoCA assessment and a quality of life QoL assessment using the SF-36 questionnaire
Data analysis For each test item within the CCAS there is a threshold score allowing a passfail determination that differentiates CCAS-positive patients from CCAS-negative patients The primary study endpoint is the percentage of patients with a positive CCAS diagnosis prior to surgery The investigators will evaluate whether CCAS is preferentially seen in association with any demographic or descriptive variables particularly tumor location in the cerebellum using chi-squared testing unless otherwise indicated Demographic data including sex age at time of brain tumor diagnosis and at surgery education level completed and dominant writing hand will be described The distribution of each of the following preoperative variables will also be described presenting symptom cognitive motor or vestibular brain lesion type newly diagnosed vs recurrent primary tumor site primary tumor histology presence or absence of a systemic burden of disease presence of hydrocephalus or previous seizure in 30 days prior to surgery prior surgery prior whole brain radiation or stereotactic radiosurgery initiation of antiepileptic or steroids prior to surgery the indication for surgery These data will be used to compare baseline characteristic of cerebellar tumor patients with non-cerebellar brain tumor patients All statistical analysis will be performed by the investigators using Prism 40 GraphPad Software Inc and Stata v10 StataCorp Lp Significance will be assessed at alpha 005
RisksBenefits There will be physical or health-related risks to the surgical resection of the patients cerebellar tumor according to the standard of care Risk is also involved to the extent that privacy and confidentiality may be compromised However every reasonable effort will be made to limit breaches of privacy and confidentiality Participants will not benefit directly from this study However the results of this work will help improve the perioperative assessment of patients with tumors of the cerebellum which may improve rehabilitation efforts in this unique patient population
Primary Aim The primary aim of this study is to determine if patients with a cerebellar tumor are more likely to test positive for cerebellar cognitive affective syndrome than patients with non-cerebellar tumors This information will be used to improve perioperative assessment in patients with tumors of the cerebellum
Secondary Aim To determine the impact of tumor location and cerebellar functional topography on perioperative outcomes determined by standard of care neurological evaluation and brain images in patients undergoing resection of cerebellar tumors This information will be used to improve perioperative assessment in patients with tumors of the cerebellum
Study Interventions Thirty-three adult 18 years of age patients with primary cerebellar brain tumors or metastatic brain tumors located in the cerebellum who will undergo surgery for tumor resection and 33 adult patients with primary non-cerebellar brain tumors or metastatic tumors located in a non-cerebellar brain location who will also undergo surgery for tumor resection will be included in this study The non-cerebellar brain tumor control group will be included for comparison Participants in this study will undergo surgical resection of their cerebellar or brain tumor as per standard of care as well as clinical and radiographic assessment including neurological physical examination including Karnofsky Performance Scale KPS if conducted per Standard of Care and magnetic resonance imaging MRI with or without diffusion tensor imaging DTItractography prior to immediately after at one-month 6-month and 1-year follow-up status post-surgical resection These data will also be collected at 18-month 60 days and 24-month 60 days visits post-surgery if regular office visits with the neurosurgeon are scheduled at these two time points Only at baseline the following will be conducted Brief Ataxia Rating Scale BARS assessment score Cerebellar Cognitive Affective Scale CCASSchmahmann syndrome scale score Montreal Cognitive Assessment MoCA assessment and a quality of life QoL assessment using the SF-36 questionnaire
Data analysis For each test item within the CCAS there is a threshold score allowing a passfail determination that differentiates CCAS-positive patients from CCAS-negative patients The primary study endpoint is the percentage of patients with a positive CCAS diagnosis prior to surgery The investigators will evaluate whether CCAS is preferentially seen in association with any demographic or descriptive variables particularly tumor location in the cerebellum using chi-squared testing unless otherwise indicated Demographic data including sex age at time of brain tumor diagnosis and at surgery education level completed and dominant writing hand will be described The distribution of each of the following preoperative variables will also be described presenting symptom cognitive motor or vestibular brain lesion type newly diagnosed vs recurrent primary tumor site primary tumor histology presence or absence of a systemic burden of disease presence of hydrocephalus or previous seizure in 30 days prior to surgery prior surgery prior whole brain radiation or stereotactic radiosurgery initiation of antiepileptic or steroids prior to surgery the indication for surgery These data will be used to compare baseline characteristic of cerebellar tumor patients with non-cerebellar brain tumor patients All statistical analysis will be performed by the investigators using Prism 40 GraphPad Software Inc and Stata v10 StataCorp Lp Significance will be assessed at alpha 005
RisksBenefits There will be physical or health-related risks to the surgical resection of the patients cerebellar tumor according to the standard of care Risk is also involved to the extent that privacy and confidentiality may be compromised However every reasonable effort will be made to limit breaches of privacy and confidentiality Participants will not benefit directly from this study However the results of this work will help improve the perioperative assessment of patients with tumors of the cerebellum which may improve rehabilitation efforts in this unique patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None