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

NCT07057895 | Completed

• 1 other identifier: 2022S00558
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Neoplasms

Keywords

GLIM criteria; PG-SGA; Pancreatic cancer; Malnutrition; Diagnostic consistency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevalence of Malnutrition according to GLIM Criteria

  Assessed once within 24 hours of hospital admission.

• Prevalence of Malnutrition according to PG-SGA

  Assessed once within 24 hours of hospital admission.

• Correlation of Assessment Tools with Nutritional Indicators

  Assessed at baseline (within 24 hours of admission).

Study Arms (1)

Nutritional Assessment Cohort

EXPERIMENTAL

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 participants in this arm receive all listed diagnostic procedures.

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

Interventions

Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment DIAGNOSTIC_TEST

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 inflammation/disease burden). Reduced muscle mass was assessed by bioelectrical impedance analysis (BIA). The assessment was performed once for each patient within 24 hours of hospital admission.

Nutritional Assessment Cohort

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

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 exam). For this study, a total score of ≥2 was considered indicative of malnutrition. The assessment was performed once for each patient within 24 hours of hospital admission.

Nutritional Assessment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

CN (1)