Pancreatic NeoplasmsNCT07057895
Diagnostic Consistency of GLIM and PG-SGA for Malnutrition in Pancreatic Cancer
A study testing Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment and Patient-Generated Subjective Global Assessment (PG-SGA) in people with Pancreatic Neoplasms, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment and Patient-Generated Subjective Global Assessment (PG-SGA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Diagnostic Consistency of the Global Leadership Initiative on Malnutrition (GLIM) Criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for Malnutrition in Patients With 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.
Read the detailed description
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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment, Patient-Generated Subjective Global Assessment (PG-SGA)
- Keywords
- GLIM criteria, PG-SGA, Pancreatic cancer, Malnutrition, Diagnostic consistency
- Medical subject headings
- Pancreatic Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Leadership Initiative on Malnutrition (GLIM) Criteria AssessmentDiagnostic 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment; Diagnostic Test: Patient-Generated Subjective Global Assessment (PG-SGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed once within 24 hours of hospital admission.
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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).
Measured: Assessed at baseline (within 24 hours of admission).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feifei Wang, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057895
- Sponsor's protocol ID
- 2022S00558
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Consistency of the Global Leadership Initiative on Malnutrition (GLIM) Criteria and the Patient-Generated Subjective Global Assessment (PG-SGA) for Malnutrition in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07057895
- Acronym / sponsor ID
- 2022S00558
- Conditions
- Pancreatic Neoplasms
- Keywords
- GLIM criteria, PG-SGA, Pancreatic cancer, Malnutrition, Diagnostic consistency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jul 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional Assessment Cohort | Experimental | Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment, Diagnostic Test: Patient-Generated Subjective Global Assessment (PG-SGA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Global Leadership Initiative on Malnutrition (GLIM) Criteria AssessmentMalnutrition 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. | Diagnostic test | Nutritional Assessment Cohort |
| 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 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. | Diagnostic test | Nutritional Assessment Cohort |
Primary outcome
Diagnostic Consistency between GLIM Criteria and PG-SGA
Time frame: Assessed once within 24 hours of hospital admission.
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.
3 secondary outcomes
Prevalence of Malnutrition according to GLIM Criteria
Time frame: Assessed once within 24 hours of hospital admission.
Prevalence of Malnutrition according to PG-SGA
Time frame: Assessed once within 24 hours of hospital admission.
Correlation of Assessment Tools with Nutritional Indicators
Time frame: Assessed at baseline (within 24 hours of admission).
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 10 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment and Patient-Generated Subjective Global Assessment (PG-SGA) in people with Pancreatic Neoplasms, run by The First Hospital of Hebei Medical University at 1 site in China.
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 5 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 10 Jul 2025. 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 China. 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?
Diagnostic Consistency between GLIM Criteria and PG-SGA (time frame: Assessed once within 24 hours of hospital admission.). 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 10 Jul 2025.