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Cognitive Assessment for Liver Surgery Patients
N/A
Waitlist Available
Led By Timothy Newhook, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* All English-speaking patients undergoing hepatectomy at main campus University of Texas (UT)-MD Anderson Cancer Center who are cognitively able to provide informed consent in the opinion of the attending physician
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing how well electronic neurocognitive tools can screen for mental capability in patients who are undergoing liver surgery. The hope is that these tools will be able to better assess mental impairment.
Who is the study for?
This trial is for English-speaking patients at UT-MD Anderson Cancer Center who are about to have liver surgery and can give informed consent. It's designed to see if they're mentally sharp enough for the procedure.
What is being tested?
The study is testing electronic tools called BrainCheck Cognitive Assessment to screen mental capability in patients before liver surgery, aiming to identify any cognitive impairments more effectively.
What are the potential side effects?
Since this trial involves non-invasive cognitive assessments, there are no direct physical side effects expected from participating in the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average time to complete the BrainCheck battery
Average time to complete the pen and paper assessment
Completion rate of the BrainCheck battery
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (BrainCheck and paper and pen cognitive assessment)Experimental Treatment2 Interventions
Patients receive the BrainCheck cognitive assessment over 15 minutes followed by the paper and pen assessment 2 months prior to surgery and within 2 months after surgery.
Group II: Group II (pen and paper and BrainCheck cognitive assessment)Active Control2 Interventions
Patients receive the paper and pen assessment followed by the BrainCheck cognitive assessment over 15 minutes 2 months prior to surgery and within 2 months after surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BrainCheck Cognitive Assessment
2020
N/A
~40
Cognitive Assessment
2011
Completed Phase 2
~1420
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,145 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,901 Total Patients Enrolled
Timothy Newhook, MDPrincipal InvestigatorM.D. Anderson Cancer Center
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