Clinical OutcomeNCT05373836
Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery
An observational study of Clinical Outcome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
There are several predictors of clinical outcome in patients undergoing brain tumor surgery. Among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Clinical Outcome
- What is being tested?
- prognostic nutritional index calculated from laboratory parameters
- How many people
- 3,263 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Dec 2024to 31 Dec 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea
Who may be able to join
- adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea
Who cannot join
- Lack of results of laboratory parameters, such as serum albumin, lymphocyte count, cholesterol
- Lack of data on clinical outcome, including mortality, acute kidney injury, renal replacement therapy, length of hospital stay, and other major adverse outcome
Trial locations and contacts
1 site in 1 country.
About this study
There are several predictors of clinical outcome in patients undergoing brain tumor surgery. Among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. However, there are lack of consistent results on predictability of nutritional index and clinical outcome in patients undergoing brain tumor surgery.
Read the detailed description
In this retrospective study, we evaluated the relationship between prognostic nutritional index, which was calculated from laboratory parameters, and clinical outcome including mortality in patients undergoing brain tumor surgery.
- Conditions
- Clinical Outcome
- Being tested
- prognostic nutritional index calculated from laboratory parameters
- Keywords
- nutritional index, brain tumor surgery, mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognostic nutritional index calculated from laboratory parametersDiagnostic test
Calculated nutritional index using laboratory results of serum albumin, lymphocyte count, and cholesterol
| Study group | Role | What they receive |
|---|---|---|
| brain tumor surgery | adult patients undergoing brain tumor surgery Receives: Diagnostic Test: prognostic nutritional index calculated from laboratory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictability of prognostic nutritional index for mortality after brain tumor surgery
Odds ratio of prognostic nutritional index for postoperative mortality
Measured: From date of surgery until the date of death from any cause, whichever came first, assessed up to 50 years
Secondary outcomes (3)
predictability of prognostic nutritional index for acute kidney injury after brain tumor surgery
Odds ratio of prognostic nutritional index for postoperative acute kidney injury
Measured: From date of surgery until the date of acute kidney injury from any cause, whichever came first, assessed up to 50 years
predictability of prognostic nutritional index for renal replacement therapy after brain tumor surgery
Odds ratio of prognostic nutritional index for postoperative renal replacement therapy
Measured: From date of surgery until the date of renal replacement therapy from any cause, whichever came first, assessed up to 50 years
relationship of prognostic nutritional index for length of hospital stay after brain tumor surgery
Odds ratio of prognostic nutritional index for length of hospital stay
Measured: From date of surgery until the date of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start12 Dec 2024
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical OutcomeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Joung Cho, MD, PhD, Seoul National University Hospital
- Investigators
- Youn Joung Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373836
- Sponsor's protocol ID
- PNI_Brain tumor
- Status last verified
- Feb 2026
- First submitted
- 24 Apr 2022
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of PNI and Clinical Outcome in Patients Undergoing Brain Tumor Surgery
- ClinicalTrials.gov ID
- NCT05373836
- Acronym / sponsor ID
- PNI_Brain tumor
- Conditions
- Clinical Outcome
- Keywords
- nutritional index, brain tumor surgery, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,263 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 May 2022 (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.
There are several predictors of clinical outcome in patients undergoing brain tumor surgery. Among those, nutritional parameters and calculated nutritional index are known to have ability to predict mortality and clinical outcomes in some patients with brain tumor. However, there are lack of consistent results on predictability of nutritional index and clinical outcome in patients undergoing brain tumor surgery.
Detailed description
In this retrospective study, we evaluated the relationship between prognostic nutritional index, which was calculated from laboratory parameters, and clinical outcome including mortality in patients undergoing brain tumor surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brain tumor surgery | – | Diagnostic Test: prognostic nutritional index calculated from laboratory parametersadult patients undergoing brain tumor surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea
Key inclusion criteria (1 listed)
- adult patients undergoing brain tumor surgery at Seoul National University Hospital, South Korea
Key exclusion criteria (2 listed)
- Lack of results of laboratory parameters, such as serum albumin, lymphocyte count, cholesterol
- Lack of data on clinical outcome, including mortality, acute kidney injury, renal replacement therapy, length of hospital stay, and other major adverse outcome
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 |
|---|---|---|
| prognostic nutritional index calculated from laboratory parametersCalculated nutritional index using laboratory results of serum albumin, lymphocyte count, and cholesterol | Diagnostic test | brain tumor surgery |
Primary outcome
predictability of prognostic nutritional index for mortality after brain tumor surgery
Time frame: From date of surgery until the date of death from any cause, whichever came first, assessed up to 50 years
Odds ratio of prognostic nutritional index for postoperative mortality
3 secondary outcomes
predictability of prognostic nutritional index for acute kidney injury after brain tumor surgery
Time frame: From date of surgery until the date of acute kidney injury from any cause, whichever came first, assessed up to 50 years
predictability of prognostic nutritional index for renal replacement therapy after brain tumor surgery
Time frame: From date of surgery until the date of renal replacement therapy from any cause, whichever came first, assessed up to 50 years
relationship of prognostic nutritional index for length of hospital stay after brain tumor surgery
Time frame: From date of surgery until the date of hospital discharge
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 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Youn Joung Cho, MD, PhD principal investigator
Seoul National University Hospital
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 Clinical Outcome, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 2 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 12 Feb 2026. 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 South Korea. 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?
predictability of prognostic nutritional index for mortality after brain tumor surgery (time frame: From date of surgery until the date of death from any cause, whichever came first, assessed up to 50 years). 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 12 Feb 2026.