Brain TumorNCT03531307
Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery
An observational study of Brain Tumor and Anesthesia, run by Ricard Valero at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Tumor, Anesthesia
- What is being tested?
- Data correlation
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2018to 2 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Craniectomy cases for tumoral and non-tumoral surgery with lactate levels and biopsy information.
Who may be able to join
- 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
Who cannot join
- Incomplete lactate or Ki-67 index information
Trial locations and contacts
1 site in 1 country.
Spain1 site
Anesthesia department, Hospital Clínic de Barcelona
Barcelona, 08036
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Tumor, Anesthesia
- Being tested
- Data correlation
- Keywords
- Lactate, Ki-67, Mitotic index, Brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data correlationOther
Correlation between lactate levels and Ki-67 index
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data correlation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 1 week after data acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start30 May 2018
- Primary completion30 Jul 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricard Valero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricard Valero, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Ricard Valero, Dr., Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531307
- Sponsor's protocol ID
- Lac001Ki67
- Status last verified
- Feb 2019
- First submitted
- 24 Apr 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Levels at Beginning of Surgery Correlates With Ki-67 Labeling Index in Brain Tumors
- ClinicalTrials.gov ID
- NCT03531307
- Acronym / sponsor ID
- Lac001Ki67
- Conditions
- Brain Tumor, Anesthesia
- Keywords
- Lactate, Ki-67, Mitotic index, Brain tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ricard ValeroUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactate and Ki 67 levels | – | Other: Data correlationNeurosurgical 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Craniectomy cases for tumoral and non-tumoral surgery with lactate levels and biopsy information.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Incomplete lactate or Ki-67 index information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data correlationCorrelation between lactate levels and Ki-67 index | Other | Lactate and Ki 67 levels |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricard Valero, Dr. principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor and Anesthesia, run by Ricard Valero at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation between Lactate levels and Ki-67 Index (time frame: Within 1 week after data acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.