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NCT03531307 Clinical Trial

Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery

Anesthesia Clinical Trial

Official title:
Lactate Levels at Beginning of Surgery Correlates With Ki-67 Labeling Index in Brain Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03531307
Other study ID # Lac001Ki67
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 30, 2018
Est. completion date August 2, 2018

Study information
Verified date February 2019
Source Fundacion Clinic per a la Recerca Biomédica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 2, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Data correlation
Correlation between lactate levels and Ki-67 index

Locations
Country Name City State
Spain Anesthesia department, Hospital Clínic de Barcelona Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Ricard Valero

Country where clinical trial is conducted

Spain, 

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