Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT02297633
Status:
UNKNOWN
Last Update Posted:
2014-11-21
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Reactive Oxygen Metabolites in the Value of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The different levels of the ROMs among different groups', 'timeFrame': '3 years', 'description': 'Apply the analysis of variance to compare the different levels of ROMs among the four different groups'}], 'secondaryOutcomes': [{'measure': 'The differences of the ROMs among the different lung function levels in the stable stage of COPD group', 'timeFrame': '3 years', 'description': 'Apply the analysis of variance to compare the differences of the ROMs among the lung function levels in the stable stage of COPD group.'}, {'measure': 'The relevance of the ROMs with the lung function levels in the stable stage of COPD group', 'timeFrame': '3 years', 'description': 'Apply Pearson correlation to compare relevance the of the ROMs with the lung function levels in the stable stage of COPD group.'}, {'measure': 'The relevance of the ROMs with the score of mMRC in the stable stage of COPD group', 'timeFrame': '3 years', 'description': 'Apply Pearson correlation to compare relevance the of the ROMs with score of mMRC in the stable stage of COPD group.'}, {'measure': 'The relevance of the ROMs with the score of CAT in the stable stage of COPD group', 'timeFrame': '3 years', 'description': 'Apply Pearson correlation to compare relevance the of the ROMs with score of CAT in the stable stage of COPD group.'}, {'measure': 'The relevance of the ROMs with the numbers of exacerbation in the stable stage of COPD group', 'timeFrame': '3 years', 'description': 'Apply Pearson correlation to compare relevance the of the ROMs with numbers of exacerbation in the stable stage of COPD group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'reactive oxygen metabolites'], 'conditions': ['COPD(Chronic Obstructive Pulmonary Disease)']}, 'descriptionModule': {'briefSummary': 'This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.', 'detailedDescription': 'Reactive oxygen metabolites (reactive oxygen metabolites, ROMs) test is a method by measuring the total reactive oxygen metabolites (ROMs) content in blood so as to evaluate the overall level of oxidative stress in the human body .Our previous studies have established the method of detecting ROMs which is suitable for fully automatic biochemical analyser.Our study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chaoyang hospital clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of COPD according to GOLD 2013\n\nExclusion Criteria:\n\n* A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training'}, 'identificationModule': {'nctId': 'NCT02297633', 'briefTitle': 'Evaluation of Reactive Oxygen Metabolites in the Value of COPD', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'System Evaluation of Reactive Oxygen Metabolites in the Value of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'BJCYYT-12345'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stability in patients with COPD', 'description': 'Those patients diagnosed COPD according to the GOLD guideline and without acute exacerbation within one month.'}, {'label': 'AECOPD', 'description': 'the diagnosis of an exacerbation relies exclusively on the clinical presentation of the patient complaining of an acute change of symptoms (baseline dyspnea, cough, and/or sputum production) that is beyond normal day-to-day variation.'}, {'label': 'Healthy persons without smoking', 'description': 'The healthy people who do not smoke'}, {'label': 'Healthy persons with smoking', 'description': 'Healthy persons who smoke'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Yang, Doctor', 'role': 'CONTACT', 'email': 'dryangting@qq.com', 'phone': '13651380809'}, {'name': 'Jie Liu, Master', 'role': 'CONTACT', 'email': 'chaoyangliujie@163.com', 'phone': '18811225394'}, {'name': 'Xiaoning Bu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hong Zhang, Master', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiaohong Chang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Baomei Wu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jingyu Quan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jie Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Huimin Gong', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hongyan Pang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Respiratory Institute;Beijing chaoyang hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ting Yang, Doctor', 'role': 'CONTACT', 'email': 'dryangting@qq.com', 'phone': '13651380809'}, {'name': 'Jie Liu, Master', 'role': 'CONTACT', 'email': 'chaoyangliujie@163.com', 'phone': '18811225394'}], 'overallOfficials': [{'name': 'Ting Yang, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Respiratory Institute, Beijing chaoyang hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Jie liu', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}