Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT03724604
Status:
UNKNOWN
Last Update Posted:
2019-05-21
First Post:
2018-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NSE/Alb as a Prognostic Biomarker for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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': 202}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-19', 'studyFirstSubmitDate': '2018-10-28', 'studyFirstSubmitQcDate': '2018-10-28', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years.', 'description': 'The time from randomization to death due to any cause. The last follow-up time is usually calculated as the time of death for those who have been lost before death.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '2 years.', 'description': 'Refers to the time from randomization to relapse or death due to disease progression. It is usually the end point after radical surgery. DFS is more difficult to record as an end point than OS because it requires careful follow-up and timely detection of disease recurrence. In this study, as an important prognostic indicator for patients undergoing NSCLC surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuron-Specific Enolase', 'Albumin', 'Prognostic Biomarker'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The incidence and mortality rate of lung cancer is the highest in the world. Current studies have found that tumor markers, inflammatory or nutritional indicators have a good predictive value for the prognosis of patients with non-small cell lung cancer (NSCLC). Neuron specific enolase (NSE) and serum albumin (Alb) are important indicators for monitoring tumor progression and nutritional status in lung cancer patients, respectively. Previous studies suggested that the higher the NSE, the worse prognosis of NSCLC patients, while the lower the Alb, the worse the prognosis of patients with malignant tumors. Through a retrospective study, the investigators found that NAR (NSE Alb Ratio) was higher and prognosis was poorer in patients undergoing NSCLC surgery. This is better than the previous assessment indicators PLR (platelet to lymphocyte ratio), NLR (neutrophil to lymphocyte ratio), AGR (albumin to globulin ratio), NAR can better assess prognosis. Therefore, on the basis of the previous retrospective analysis, the optimal NAR cut-off value was calculated according to ROC curve, and the value was grouped into multi-center prospective cohort study, and the relationship between NAR and other clinical indicators was studied by chi-square test. Univariate and multivariate analysis of Cox proportional hazard regression model was used to determine the prognostic factors. Finally, NSCLC patients were stratified according to tumor stage and pathological classification, and the differences of survival time between high NAR group and low NAR group were compared again under different stages and types, and the different stages of NAR in NSCLC patients were further analyzed. The clinical significance of typing. By exploring and validating the relationship between NAR and the prognosis of NSCLC patients, the investigators try to establish a new prognostic index. Obviously, it has important value for clinical application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Sample sources: Xi'an Jiaotong University First Affiliated Hospital, Second Affiliated Hospital, Shaanxi Provincial People's Hospital, Shaanxi Provincial Cancer Hospital and other hospitals.\n\nSubject recruitment process:\n\n1. Subject screening: Subjects were screened according to inclusion and exclusion criteria.\n2. Recruitment of the research subject: In the course of clinical diagnosis and treatment, the competent doctor recruits.\n3. Subject informed consent: inform patients to collect their clinical data and follow up for clinical studies, signing informed consent.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) pathological diagnosis of non-small cell lung cancer\n* (2) 18-70 years of age and no gender restriction.\n* (3) patients who were admitted for the first time and underwent routine blood tests, three lung cancer and liver function tests.\n\nExclusion Criteria:\n\n* (1) pregnant or lactating women\n* (2) patients with other malignancies at the same time\n* (3) patients with acute and chronic inflammation, autoimmune diseases, and patients with obvious liver and renal insufficiency.\n* (4) patients with incomplete clinical and pathological data.'}, 'identificationModule': {'nctId': 'NCT03724604', 'acronym': 'NARPBLC', 'briefTitle': 'NSE/Alb as a Prognostic Biomarker for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2017-020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high NAR', 'description': 'Neuron-Specific Enolase to Albumin Ratio is higher than 3.2×10-7', 'interventionNames': ['Diagnostic Test: Neuron-Specific Enolase to Albumin Ratio']}, {'label': 'low NAR', 'description': 'Neuron-Specific Enolase to Albumin Ratio is lower than 3.2×10-7', 'interventionNames': ['Diagnostic Test: Neuron-Specific Enolase to Albumin Ratio']}], 'interventions': [{'name': 'Neuron-Specific Enolase to Albumin Ratio', 'type': 'DIAGNOSTIC_TEST', 'description': 'Previous studies have shown that inflammation and nutrition-related factors such as CRP/Alb (C-reactive protein-albumin ratio), PLR (platelet-to-lymphocyte ratio), NLR (neutrophil-to-lymphocyte ratio) can help to assess the prognosis of malignant tumors. This study is the first time to combine NSCLC tumor marker NSE and patient nutrition-related indicators Alb to predict the prognosis of patients, trying to find high sensitivity and specificity for NSCLC prognostic indicators to guide clinical work.', 'armGroupLabels': ['high NAR', 'low NAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sida Qin', 'role': 'CONTACT', 'email': 'sida.qin@yahoo.com', 'phone': '+8615829916265'}], 'facility': "First hospital affiliated Xi'an jiaotong university", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Sida Qin, MD PhD', 'role': 'CONTACT', 'email': 'sida.qin@yahoo.com', 'phone': '+8615829916265'}], 'overallOfficials': [{'name': 'Sida Qin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'Shaanxi Provincial Cancer Hospital', 'class': 'OTHER'}, {'name': "Shaanxi Provincial People's Hospital", 'class': 'OTHER'}, {'name': "Xi'an Central Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}