Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-30 @ 1:03 PM
Study NCT ID:
NCT07057895
Status:
COMPLETED
Last Update Posted:
2025-07-10
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Consistency of GLIM and PG-SGA for Malnutrition in Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Consistency between GLIM Criteria and PG-SGA', 'timeFrame': 'Assessed once within 24 hours of hospital admission.', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Prevalence of Malnutrition according to GLIM Criteria', 'timeFrame': 'Assessed once within 24 hours of hospital admission.', 'description': '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).'}, {'measure': 'Prevalence of Malnutrition according to PG-SGA', 'timeFrame': 'Assessed once within 24 hours of hospital admission.', 'description': 'The percentage of patients identified as malnourished based on the PG-SGA. A total score of ≥2 was considered indicative of malnutrition.'}, {'measure': 'Correlation of Assessment Tools with Nutritional Indicators', 'timeFrame': 'Assessed at baseline (within 24 hours of admission).', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GLIM criteria', 'PG-SGA', 'Pancreatic cancer', 'Malnutrition', 'Diagnostic consistency'], 'conditions': ['Pancreatic Neoplasms']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologically confirmed pancreatic malignant tumor.\n* Age ≥ 18 years.\n* Clear cognition and ability to communicate verbally.\n* Nutritional Risk Screening 2002 (NRS 2002) score ≥ 3.\n* Provision of written informed consent to participate.\n\nExclusion Criteria:\n\n* Presence of severe cardiac, hepatic, or renal comorbidities.\n* Bedridden status precluding weight measurement.\n* Contraindications to bioelectrical impedance analysis (e.g., implanted electronic devices, amputation).\n* Concurrent diagnosis of other malignant tumors, particularly of the digestive system.\n* Inability to cooperate with questionnaire completion or assessments.'}, 'identificationModule': {'nctId': 'NCT07057895', 'briefTitle': 'Diagnostic Consistency of GLIM and PG-SGA for Malnutrition in Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Hebei Medical University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2022S00558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutritional Assessment Cohort', 'description': '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.', 'interventionNames': ['Diagnostic Test: Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment', 'Diagnostic Test: Patient-Generated Subjective Global Assessment (PG-SGA)']}], 'interventions': [{'name': 'Global Leadership Initiative on Malnutrition (GLIM) Criteria Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Nutritional Assessment Cohort']}, {'name': 'Patient-Generated Subjective Global Assessment (PG-SGA)', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Nutritional Assessment Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Feifei Wang', 'investigatorAffiliation': 'The First Hospital of Hebei Medical University'}}}}