Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery

February 13, 2019 updated by: Ricard Valero

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

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08036
        • Anesthesia department, Hospital Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Craniectomy cases for tumoral and non-tumoral surgery with lactate levels and biopsy information.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Correlation between lactate levels and Ki-67 index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the correlation between Lactate levels and Ki-67 Index
Time Frame: Within 1 week after data acquisition
Levels of lactate in first blood analysis after anesthesia induction and proliferation index in biopsy results
Within 1 week after data acquisition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ricard Valero, Dr., Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 30, 2018

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

August 2, 2018

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (ACTUAL)

May 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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