Diagnostic Consistency Of GLIM And PG-SGA For Malnutrition In Pancreatic Cancer

Study Overview

Diagnostic Consistency of GLIM and PG-SGA for Malnutrition in Pancreatic Cancer

This study aimed to evaluate the diagnostic consistency between the Global Leadership Initiative on Malnutrition (GLIM) criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for identifying malnutrition in patients with pancreatic malignant tumors. The goal is to determine if the GLIM criteria, a newer and more streamlined tool, shows substantial agreement with the well-established PG-SGA, thereby supporting its use in this high-risk clinical population.

Pancreatic cancer is a highly aggressive malignancy often associated with severe nutritional decline. While the Nutritional Risk Screening 2002 (NRS 2002) is used for initial screening and the Patient-Generated Subjective Global Assessment (PG-SGA) is a recognized standard for detailed nutritional assessment, the PG-SGA can be time-consuming. The Global Leadership Initiative on Malnutrition (GLIM) criteria were developed to provide a globally harmonized, two-step framework for diagnosing malnutrition. This prospective observational study was designed to compare the performance of GLIM criteria against the PG-SGA in patients with pancreatic cancer. Patients admitted to the hospital were screened with NRS 2002. Those at nutritional risk (NRS 2002 ≥ 3) were then comprehensively assessed using both PG-SGA and GLIM criteria. The study hypothesis is that the GLIM criteria and PG-SGA will demonstrate good consistency in diagnosing malnutrition in this population, validating GLIM as a practical and reliable assessment tool in clinical settings.

Pancreatic Neoplasms

DIAGNOSTIC_TEST: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment
DIAGNOSTIC_TEST: Patient-Generated Subjective Global Assessment (PG-SGA)

2022S00558

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-07-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-01
First Submitted that Met QC Criteria 2025-07-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-10
First Posted (ACTUAL) 2025-07-10	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Nutritional Assessment Cohort A single cohort of patients with pancreatic cancer and nutritional risk (NRS 2002 ≥ 3) who underwent comprehensive nutritional assessment using both the GLIM criteria and the PG-SGA to evaluate the diagnostic consistency between the two tools. All partici	DIAGNOSTIC_TEST: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment Malnutrition was diagnosed according to the GLIM consensus criteria. This required at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammatio DIAGNOSTIC_TEST: Patient-Generated Subjective Global Assessment (PG-SGA) A comprehensive nutritional assessment administered by trained clinical staff. The tool comprises patient-reported sections (weight history, food intake, symptoms, activities/function) and clinician-assessed sections (disease, metabolic demand, physical e

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Nutritional Assessment Cohort

A single cohort of patients with pancreatic cancer and nutritional risk (NRS 2002 ≥ 3) who underwent comprehensive nutritional assessment using both the GLIM criteria and the PG-SGA to evaluate the diagnostic consistency between the two tools. All partici

DIAGNOSTIC_TEST: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment

Malnutrition was diagnosed according to the GLIM consensus criteria. This required at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammatio

DIAGNOSTIC_TEST: Patient-Generated Subjective Global Assessment (PG-SGA)

A comprehensive nutritional assessment administered by trained clinical staff. The tool comprises patient-reported sections (weight history, food intake, symptoms, activities/function) and clinician-assessed sections (disease, metabolic demand, physical e

Primary Outcome Measures	Measure Description	Time Frame
Diagnostic Consistency between GLIM Criteria and PG-SGA	The consistency in diagnosing malnutrition (yes/no) between the GLIM criteria and the PG-SGA was assessed. The agreement was quantified using Cohen's kappa coefficient (κ). A kappa value of 0.61-0.80 was interpreted as substantial agreement.	Assessed once within 24 hours of hospital admission.

Secondary Outcome Measures	Measure Description	Time Frame
Prevalence of Malnutrition according to GLIM Criteria	The percentage of patients diagnosed with malnutrition based on the GLIM criteria, which requires at least one phenotypic criterion (non-volitional weight loss, low BMI, or reduced muscle mass) and one etiologic criterion (reduced food intake/assimilation or inflammation/disease burden).	Assessed once within 24 hours of hospital admission.
Prevalence of Malnutrition according to PG-SGA	The percentage of patients identified as malnourished based on the PG-SGA. A total score of ≥2 was considered indicative of malnutrition.	Assessed once within 24 hours of hospital admission.
Correlation of Assessment Tools with Nutritional Indicators	The correlation between the malnutrition diagnosis (by GLIM and PG-SGA) and traditional nutritional indicators was assessed using Pearson correlation analysis. The indicators included mid-upper arm circumference (AC), calf circumference (CC), Body Mass Index (BMI), serum albumin (Alb), and hemoglobin (Hb).	Assessed at baseline (within 24 hours of admission).

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histopathologically confirmed pancreatic malignant tumor.
Age ≥ 18 years.
Clear cognition and ability to communicate verbally.
Nutritional Risk Screening 2002 (NRS 2002) score ≥ 3.
Provision of written informed consent to participate.

Presence of severe cardiac, hepatic, or renal comorbidities.
Bedridden status precluding weight measurement.
Contraindications to bioelectrical impedance analysis (e.g., implanted electronic devices, amputation).
Concurrent diagnosis of other malignant tumors, particularly of the digestive system.
Inability to cooperate with questionnaire completion or assessments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record