Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-03 @ 2:34 PM
Study NCT ID:
NCT07151794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
G8, CARG, Frailty, and Nutritional Markers in Predicting Chemotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-09-01', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side effects of chemotherapy', 'timeFrame': 'From enrollment to 6 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['G-CSF', 'CARG', 'Frailty', 'Mini Nutritional Assessment (MNA)'], 'conditions': ['Geriatric Oncology', 'Oncology', 'Nutrition', 'Nutrition Assessment']}, 'referencesModule': {'references': [{'pmid': '22250183', 'type': 'BACKGROUND', 'citation': 'Bellera CA, Rainfray M, Mathoulin-Pelissier S, Mertens C, Delva F, Fonck M, Soubeyran PL. Screening older cancer patients: first evaluation of the G-8 geriatric screening tool. Ann Oncol. 2012 Aug;23(8):2166-2172. doi: 10.1093/annonc/mdr587. Epub 2012 Jan 16.'}, {'pmid': '33028215', 'type': 'BACKGROUND', 'citation': 'Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.'}, {'type': 'BACKGROUND', 'citation': 'Kenis, C., Bron, D., Libert, Y., et al., Relevance of a geriatric assessment in older patients with cancer: a systematic review, Journal of Geriatric Oncology, 2014, 5(2): 3-9.'}, {'pmid': '24936581', 'type': 'BACKGROUND', 'citation': 'Decoster L, Van Puyvelde K, Mohile S, Wedding U, Basso U, Colloca G, Rostoft S, Overcash J, Wildiers H, Steer C, Kimmick G, Kanesvaran R, Luciani A, Terret C, Hurria A, Kenis C, Audisio R, Extermann M. Screening tools for multidimensional health problems warranting a geriatric assessment in older cancer patients: an update on SIOG recommendationsdagger. Ann Oncol. 2015 Feb;26(2):288-300. doi: 10.1093/annonc/mdu210. Epub 2014 Jun 16.'}, {'type': 'BACKGROUND', 'citation': 'Wildiers, H., Heeren, P., Puts, M., et al., Comprehensive geriatric assessment (CGA) in older patients with cancer: facts and future, The Lancet Oncology, 2014, 15(5): e184-e192.'}, {'pmid': '21810685', 'type': 'BACKGROUND', 'citation': 'Hurria A, Togawa K, Mohile SG, Owusu C, Klepin HD, Gross CP, Lichtman SM, Gajra A, Bhatia S, Katheria V, Klapper S, Hansen K, Ramani R, Lachs M, Wong FL, Tew WP. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011 Sep 1;29(25):3457-65. doi: 10.1200/JCO.2011.34.7625. Epub 2011 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the ability of G8, CARG, and Frailty scales to predict chemotherapy-related toxicity and the need for G-CSF in elderly cancer patients. It also investigates their correlation with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP) and the Mini Nutritional Assessment (MNA) test.', 'detailedDescription': 'Background: Aging is associated with decreased physiological reserves, making elderly cancer patients more vulnerable to chemotherapy toxicity (CT). Traditional performance scales like ECOG may be insufficient for treatment decisions. Tools such as G8, Clinical Frailty Scale (CFS), and the Cancer and Aging Research Group (CARG) score are practical screening instruments recommended by ASCO and SIOG, yet their combined predictive accuracy for CT and granulocyte colony-stimulating factor (G-CSF) usage remains underexplored.\n\nObjectives: This prospective study aims to evaluate the predictive performance of the G8, CARG, and Frailty scales-alone and in combination with nutritional biomarkers (albumin, prealbumin, hemoglobin, CRP)-in forecasting chemotherapy-related toxicity and G-CSF need. It also investigates the correlation between these geriatric assessment tools and Mini Nutritional Assessment (MNA) scores.\n\nMethods: The study will be conducted at Çanakkale University Medical Faculty Oncology Outpatient Clinic. Patients aged 65 and above with a planned chemotherapy regimen will be recruited. Before the first chemotherapy cycle, patients will undergo G8, CARG, Frailty, and MNA assessments. Nutritional biomarkers will be extracted from pre-treatment routine lab tests. Chemotherapy toxicity and G-CSF requirement will be monitored across treatment cycles. ROC, correlation, and regression analyses will be conducted to evaluate predictive validity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* Diagnosed with solid tumor malignancy\n* Planned to undergo at least two cycles of adjuvant, neoadjuvant, or metastatic chemotherapy\n* Clinically stable condition\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Presence of hematological malignancies\n* Concurrent hormonal therapy, targeted therapy, immunotherapy, or radiotherapy\n* Acute infection or advanced organ failure (cardiac, hepatic, renal)\n* Cognitive or psychiatric impairment preventing test participation\n* Prior treatment with G-CSF'}, 'identificationModule': {'nctId': 'NCT07151794', 'briefTitle': 'G8, CARG, Frailty, and Nutritional Markers in Predicting Chemotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Çanakkale Onsekiz Mart University'}, 'officialTitle': 'Correlation of G8, CARG, and Frailty Scales With Nutritional Biomarkers and G-CSF Requirement in Elderly Cancer Patients: A Prospective Study on Predicting Chemotherapy Toxicity', 'orgStudyIdInfo': {'id': 'COMU-FNO-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'The study group consists of cancer patients aged 65 and older who are scheduled to receive at least two cycles of chemotherapy. Patients with hematological malignancies or receiving concurrent targeted, hormonal, immunotherapy, or radiotherapy are excluded.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17020', 'city': 'Çanakkale', 'country': 'Turkey (Türkiye)', 'facility': 'Çanakkale Onsekiz Mart Univercity', 'geoPoint': {'lat': 40.15552, 'lon': 26.41271}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Çanakkale Onsekiz Mart University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research asistant', 'investigatorFullName': 'Cemre Aydeğer', 'investigatorAffiliation': 'Çanakkale Onsekiz Mart University'}}}}