Prognostic Nutritional IndexNCT07794722
Prognostic Nutritional Index and Postoperative Complications in Oncologic Surgery
An observational study of Prognostic Nutritional Index, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Malnutrition, anorexia, and cachexia are common in patients undergoing oncologic surgery and can negatively affect treatment outcomes. The Prognostic Nutritional Index (PNI), calculated from serum albumin levels and total lymphocyte count, is a simple and reliable marker of nutritional and immune status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prognostic Nutritional Index
- How many people
- 1,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2026to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who met the inclusion criteria, were not excluded according to the exclusion criteria, and underwent oncologic surgery between the opening date of our hospital and the date of ethics committee approval will be included in the study.
Who may be able to join
- Kocaeli City Hospital, all patients over 18 years old who have undergone oncologic surgery
Who cannot join
- Patients under 18 years of age
- Patients with a history of bone marrow suppression or hematologic malignancy
- Patients admitted as emergency cases
- Patients who received albumin replacement within 1 month prior to surgery (preoperative period)
- Patients who received chemotherapy/radiotherapy within the last 1 year
- Patients who received immunosuppressive therapy within the last 1 year
- Patients who received blood or blood product replacement within 1 month prior to surgery (preoperative period)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Prognostic Nutritional Index and Postoperative Complications in Patients Undergoing Oncologic Surgery: A Retrospective Cohort Study
Malnutrition, anorexia, and cachexia are common in patients undergoing oncologic surgery and can negatively affect treatment outcomes. The Prognostic Nutritional Index (PNI), calculated from serum albumin levels and total lymphocyte count, is a simple and reliable marker of nutritional and immune status. Although PNI has been studied in various malignancies, its predictive value for postoperative outcomes across all oncologic surgical procedures has not been fully evaluated. This study aims to assess the role of PNI in predicting postoperative outcomes and prognosis in patients undergoing different types of oncologic surgery.
Read the detailed description
Anorexia, malnutrition, and cachexia are commonly observed in patients undergoing oncologic surgery . Although these issues are more pronounced in advanced-stage disease, they can also occur in early-stage malignancies and adversely affect treatment outcomes. Various methods and tests are used to assess patients' nutritional status, including the Malnutrition Universal Screening Tool (MUST) for community screening, the Nutritional Risk Screening (NRS) for hospitalized patients, and the Mini Nutritional Assessment (MNA) for elderly patients. Some of these tools are simple, consisting of only a few parameters, while others are more complex, incorporating clinical, laboratory, and technological measurements . Examples of these scales include the Subjective Global Assessment (SGA) and the Patient-Generated Subjective Global Assessment (PG-SGA) . Nutritional assessment methods have generally been reported to be useful in predicting treatment response, tolerance, and prognosis.
One such tool, the Prognostic Nutritional Index (PNI), was first proposed by Onodera et al. as a novel prognostic score based on systemic inflammation, calculated using the combination of lymphocyte count and serum albumin levels. PNI is relatively simple, relies on fewer parameters, and is easy to apply . It is calculated using the formula:
PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])
Onodera et al. demonstrated that PNI values above 45 can be used reliably, although the optimal cut-off value may vary . Hypoalbuminemia is an independent predictor of in-hospital and long-term adverse outcomes . Serum albumin (SA) is a negative marker of inflammation, as its concentration decreases in the presence of inflammatory processes . It also serves as an abundant and important circulating antioxidant, participating in ligand binding and free radical scavenging activities . Lymphocyte count reflects immune function; low lymphocyte levels have been associated with pre-existing immunosuppression, leading to inadequate immune responses in cardiovascular diseases. Patients with lymphopenia are more likely to develop endothelial dysfunction, platelet activation, and thrombogenesis. Total lymphocyte count (TLC) is an immuno-inflammatory biomarker, and lymphopenia is more likely to develop in the setting of inflammation-associated lymphocyte apoptosis .
PNI has been used as a prognostic marker in various malignancies, pulmonary embolism, and other diseases. It has been shown to be an effective indicator of nutritional and immunological status in cancer patients and to influence patient prognosis through local immune responses . Although the predictive value of PNI has been studied for postoperative mortality, treatment response, and prognosis in different oncologic surgeries, there is no study evaluating its prognostic role across all patients undergoing oncologic surgery . This study aims to assess the impact of PNI on postoperative outcomes in patients undergoing various oncologic surgical procedures.
- Conditions
- Prognostic Nutritional Index
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prognostic Nutritional Index (PNI) may be a predictor of 30-day and 90-day mortality in patients undergoing oncologic surgery.
The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 30-day and 90-day mortality will be evaluated in patients undergoing oncologic surgery.
Measured: the 30-day periods following oncologic surgery
Secondary outcomes (7)
The Prognostic Nutritional Index (PNI) may be a predictor of 90-day mortality in patients undergoing oncologic surgery.
The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 90-day mortality will be evaluated in patients undergoing oncologic surgery.
The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 90-day mortality will be evaluated in patients undergoing oncologic surgery.
Measured: the 90-day periods following oncologic surgery
Incidence of acute kidney injury
Predictive value of preoperative PNI for the incidence of acute kidney injury within 3 months after oncologic surgery.
Measured: 3 months postoperatively
Wound healing
The predictive value of preoperative PNI for wound healing will be evaluated, based on assessments documented in outpatient clinic and ward notes.
Measured: 90 days postoperatively(assessed via outpatient and ward follow-up notes)
Thromboembolic events
The predictive value of preoperative PNI for the risk of thromboembolic events within 30 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.
Measured: 30 days postoperatively
Revision surgery
The predictive value of preoperative PNI for the need for revision surgery within 90 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.
Measured: 90 days postoperatively
Need for cardiopulmonary resuscitation (CPR)
The predictive value of preoperative PNI for the need for cardiopulmonary resuscitation within 90 days after oncologic surgery will be evaluated in patients undergoing oncologic surgery.
Measured: 90 days postoperatively
Intraoperative and postoperative bleeding
The predictive value of preoperative PNI for the risk of intraoperative and postoperative bleeding will be evaluated in patients undergoing oncologic surgery.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start29 Mar 2026
- Primary completion10 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prognostic Nutritional IndexStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ayşe Z Turan Cıvraz, Assoc. Prof., Principal investigator, kocaeli şehir hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794722
- Sponsor's protocol ID
- KSH-ERK-1
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Prognostic Nutritional Index and Postoperative Complications in Patients Undergoing Oncologic Surgery: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07794722
- Acronym / sponsor ID
- KSH-ERK-1
- Conditions
- Prognostic Nutritional Index
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 29 Mar 2026 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 31 Aug 2026 (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.
Malnutrition, anorexia, and cachexia are common in patients undergoing oncologic surgery and can negatively affect treatment outcomes. The Prognostic Nutritional Index (PNI), calculated from serum albumin levels and total lymphocyte count, is a simple and reliable marker of nutritional and immune status. Although PNI has been studied in various malignancies, its predictive value for postoperative outcomes across all oncologic surgical procedures has not been fully evaluated. This study aims to assess the role of PNI in predicting postoperative outcomes and prognosis in patients undergoing different types of oncologic surgery.
Detailed description
Anorexia, malnutrition, and cachexia are commonly observed in patients undergoing oncologic surgery . Although these issues are more pronounced in advanced-stage disease, they can also occur in early-stage malignancies and adversely affect treatment outcomes. Various methods and tests are used to assess patients' nutritional status, including the Malnutrition Universal Screening Tool (MUST) for community screening, the Nutritional Risk Screening (NRS) for hospitalized patients, and the Mini Nutritional Assessment (MNA) for elderly patients. Some of these tools are simple, consisting of only a few parameters, while others are more complex, incorporating clinical, laboratory, and technological measurements . Examples of these scales include the Subjective Global Assessment (SGA) and the Patient-Generated Subjective Global Assessment (PG-SGA) . Nutritional assessment methods have generally been reported to be useful in predicting treatment response, tolerance, and prognosis.
One such tool, the Prognostic Nutritional Index (PNI), was first proposed by Onodera et al. as a novel prognostic score based on systemic inflammation, calculated using the combination of lymphocyte count and serum albumin levels. PNI is relatively simple, relies on fewer parameters, and is easy to apply . It is calculated using the formula:
PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])PNI=Serum albumin (g/L)+(5×Total lymphocyte count [109/L])
Onodera et al. demonstrated that PNI values above 45 can be used reliably, although the optimal cut-off value may vary . Hypoalbuminemia is an independent predictor of in-hospital and long-term adverse outcomes . Serum albumin (SA) is a negative marker of inflammation, as its concentration decreases in the presence of inflammatory processes . It also serves as an abundant and important circulating antioxidant, participating in ligand binding and free radical scavenging activities . Lymphocyte count reflects immune function; low lymphocyte levels have been associated with pre-existing immunosuppression, leading to inadequate immune responses in cardiovascular diseases. Patients with lymphopenia are more likely to develop endothelial dysfunction, platelet activation, and thrombogenesis. Total lymphocyte count (TLC) is an immuno-inflammatory biomarker, and lymphopenia is more likely to develop in the setting of inflammation-associated lymphocyte apoptosis .
PNI has been used as a prognostic marker in various malignancies, pulmonary embolism, and other diseases. It has been shown to be an effective indicator of nutritional and immunological status in cancer patients and to influence patient prognosis through local immune responses . Although the predictive value of PNI has been studied for postoperative mortality, treatment response, and prognosis in different oncologic surgeries, there is no study evaluating its prognostic role across all patients undergoing oncologic surgery . This study aims to assess the impact of PNI on postoperative outcomes in patients undergoing various oncologic surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who met the inclusion criteria, were not excluded according to the exclusion criteria, and underwent oncologic surgery between the opening date of our hospital and the date of ethics committee approval will be included in the study.
Key inclusion criteria (1 listed)
- Kocaeli City Hospital, all patients over 18 years old who have undergone oncologic surgery
Key exclusion criteria (7 listed)
- Patients under 18 years of age
- Patients with a history of bone marrow suppression or hematologic malignancy
- Patients admitted as emergency cases
- Patients who received albumin replacement within 1 month prior to surgery (preoperative period)
- Patients who received chemotherapy/radiotherapy within the last 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Prognostic Nutritional Index (PNI) may be a predictor of 30-day and 90-day mortality in patients undergoing oncologic surgery.
Time frame: the 30-day periods following oncologic surgery
The predictive power of the preoperative Prognostic Nutritional Index (PNI), calculated using albumin and lymphocyte values, for 30-day and 90-day mortality will be evaluated in patients undergoing oncologic surgery.
7 secondary outcomes
The Prognostic Nutritional Index (PNI) may be a predictor of 90-day mortality in patients undergoing oncologic surgery.
Time frame: the 90-day periods following oncologic surgery
Incidence of acute kidney injury
Time frame: 3 months postoperatively
Wound healing
Time frame: 90 days postoperatively(assessed via outpatient and ward follow-up notes)
Thromboembolic events
Time frame: 30 days postoperatively
Revision surgery
Time frame: 90 days postoperatively
Need for cardiopulmonary resuscitation (CPR)
Time frame: 90 days postoperatively
Intraoperative and postoperative bleeding
Time frame: 30 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
Ayşe Z Turan Cıvraz, Assoc. Prof. principal investigator
kocaeli şehir hastanesi
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 Prognostic Nutritional Index, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
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 7 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: under way, not looking for participants, as of the sponsor's last update on 31 Aug 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
The Prognostic Nutritional Index (PNI) may be a predictor of 30-day and 90-day mortality in patients undergoing oncologic surgery. (time frame: the 30-day periods following oncologic surgery). 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 31 Aug 2026.