NCT03531307

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

April 24, 2018

Last Update Submit

February 13, 2019

Conditions

Brain TumorAnesthesia

Keywords

LactateKi-67Mitotic indexBrain tumor

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Other: Data correlation

Interventions

Data correlationOTHER

Correlation between lactate levels and Ki-67 index

Lactate and Ki 67 levels

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Incomplete lactate or Ki-67 index information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia department, Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ricard Valero, Dr.

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Neuroanesthesia. Associated Professor.

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 21, 2018

Study Start

May 30, 2018

Primary Completion

July 30, 2018

Study Completion

August 2, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)