Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT04306094
Status:
UNKNOWN
Last Update Posted:
2020-03-12
First Post:
2020-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Determining the Prognosis in NSCLC Stage IV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 217}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 months', 'description': 'to assess overall survival in patients with NSCLC'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prognostic factor', 'survival', 'lung cancer'], 'conditions': ['NSCLC Stage IV']}, 'referencesModule': {'references': [{'pmid': '36161783', 'type': 'DERIVED', 'citation': 'Cunha MT, de Souza Borges AP, Carvalho Jardim V, Fujita A, de Castro G Jr. Predicting survival in metastatic non-small cell lung cancer patients with poor ECOG-PS: A single-arm prospective study. Cancer Med. 2023 Feb;12(4):5099-5109. doi: 10.1002/cam4.5254. Epub 2022 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is a cohort study with patients with advanced NSCLC. Patients will answer questionnaires about symptoms and quality of life and will be submitted to physical and blood tests, and computer tomography. The aim of this study is to estimate prognostic factors predicting survival to 3 months in patients with advanced NSCLC.', 'detailedDescription': "Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil. NSCLC has a high incidence, is usually diagnosed in advanced stages and has poor survival rates. The ability to refine the prognosis of a disease has implications at the time of diagnosis and decision about treatment. Clinical and laboratory factors are studied to evaluated the prognosis of diseases. Palliative Prognostic Score (PaP score), Karnofsky Performance Status Scale (KPS), Palliative Prognostic Index (PPI) are applied in patients with many types of solid tumors. The Charlson Score evaluates comorbidities and the attributed risk for presence it. Others predictors of prognostic are cachexia, quality of life, inflammatory factors, sarcopenia. There is a need to improve the ability to estimate the prognosis and to identify the factors responsible to low survival rates in patients with NSCLC diagnosed at advanced stage, also as a tool for a better treatment selection.\n\nThis is an observational and prospective study, including patients diagnosed with NSCLC and admitted in ICESP, staged as IV at admission, with no previous systemic treatment and classified as ECOG 2-4. Demographic data, presence of a caregiver, anthropometry, MRC dyspnea scale, KPS, Edmont Symptom Scale, Charlson's Comorbidity Score, PPI and PaP were evaluated in each patient. Evaluation of sarcopenia and cachexia with abdominal CT (Slice-O-Matic, v.5), arm circumference, handgrip strength test and quality of life using EORTC score QLQ C-30 and QLQ-CAX-24 were also evaluated. Significant prognostic factors will be selected by multivariate analysis in a training set estimated as 217 patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NSCLC patient, treatment naive with Eastern Cooperative Oncology Group Performance status 2-4 (ECOG PS).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced stage IVa or IVb NSCLC patients histologically diagnosis.\n* Eastern Cooperative Oncology Group Performance status 2 - 4\n* Treatment-naive\n\nExclusion Criteria:\n\n* Initiate treatment before initiate\n* psychiatric illnesses, except depression\n* pregnant or breastfeeding women\n* two concomitant neoplasms'}, 'identificationModule': {'nctId': 'NCT04306094', 'acronym': 'LUPROG', 'briefTitle': 'Factors Determining the Prognosis in NSCLC Stage IV', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Predictive Prognostic Factors in Patients With Non-small Cell Lung Cancer Stage IV', 'orgStudyIdInfo': {'id': 'NP1105/17'}}, 'contactsLocationsModule': {'locations': [{'zip': '04513100', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'ana p borges', 'role': 'CONTACT', 'email': 'aninhapsb@gmail.com', 'phone': '11969057406'}], 'facility': 'Ana Paula de Souza Borges', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'ana p borges', 'role': 'CONTACT', 'email': 'aninhapsb@gmail.com', 'phone': '+5511969057406'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician, MD', 'investigatorFullName': 'Ana Paula de Souza Borges', 'investigatorAffiliation': 'Instituto do Cancer do Estado de São Paulo'}}}}