- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531307
Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery
Lactate Levels at Beginning of Surgery Correlates With Ki-67 Labeling Index in Brain Tumors
In neurosurgery, brain tumor patients show increased levels of lactate at the beginning of surgery. This has been related to malignancy. Ki-67 is a cell proliferation index used as a marker of tumor mitotic activity.
This research aims to describe the correlation between lactate levels and the Ki-67 index in patients with brain tumor.
Study Overview
Detailed Description
Lactate levels are used in the evaluation of perfusion status in critical care. Increases not related to a hypoperfusion state are observed in the patient with brain tumors. These increases have been related to type and tumor grade. This observation does not fully explain the variation within the same tumor grade.
Ki-67 label index is a marker of mitotic activity that can be used as proliferation index. It has been associated with histologic grade and survival rate. Provides a quantitative measure of the tumor proliferation status.
The investigators will perform a retrospective analysis of the clinical charts of patients after brain tumor resection. The study will address the relationship between baseline lactate levels and the proliferation index found in tissues biopsies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08036
- Anesthesia department, Hospital Clínic de Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Neurosurgical craniectomy cases
- June 2017 - February 2018
- Valid lactate information after anesthesia induction
- Ki-67 label index informed in biopsies
- Tumor type information confirmed in biopsies
Exclusion Criteria:
- Incomplete lactate or Ki-67 index information
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Lactate and Ki 67 levels
Neurosurgical patients between June 2017 and February 2018 for tumoral and non-tumoral craniectomy with lactate levels at the beginning of surgery and Ki-67 index in biopsies.
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Correlation between lactate levels and Ki-67 index
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluate the correlation between Lactate levels and Ki-67 Index
Time Frame: Within 1 week after data acquisition
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Levels of lactate in first blood analysis after anesthesia induction and proliferation index in biopsy results
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Within 1 week after data acquisition
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ricard Valero, Dr., Hospital Clinic of Barcelona
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lac001Ki67
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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