Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-30 @ 12:14 AM
Study NCT ID:
NCT05016466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-08-23
First Post:
2021-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-16', 'studyFirstSubmitDate': '2021-07-26', 'studyFirstSubmitQcDate': '2021-08-16', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline of Diffusion Capacity (DLCO) at 5 years', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'To determine the value of DLCO in COPD screening in smokers and ex-smokers with respiratory symptoms and normal spirometry (GOLD 0)'}], 'secondaryOutcomes': [{'measure': 'Risk factors associated to the development of COPD', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Risk factors associated to the development of COPD'}, {'measure': 'Changes from baseline of inflammatory Markers at 2 and 5 years', 'timeFrame': '2 and 5 years', 'description': 'To Study soluble receptors involved in inflammation processes and tissue repair in early disease stages.'}, {'measure': 'Oxidative stress', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'To Study of oxidative stress parameters in early disease stages'}, {'measure': 'Diffusion study', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'To Characterize patients in stage 0 of GOLD with impaired diffusion'}, {'measure': 'Changes from baseline of High Resolution Computed Tomography (HRTC) at 5 years', 'timeFrame': 'Baseline and 5 years', 'description': 'To determine changes in HRCT to identify subgroups of patients with different clinical and evolutionary trajectories'}, {'measure': 'Airflow limitation Study', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'To Investigate the contribution of measuring lung volumes for the diagnosis of COPD when there is no evidence of airflow limitation in spirometry (GOLD 0).'}, {'measure': 'Gender differences in value of diffusion (DLCO)', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'To assess if there are differences between men and women with diffusion disorder'}, {'measure': 'Childhood background', 'timeFrame': 'Baseline', 'description': 'To assess whether factors, such as the effect of lung development during childhood and adolescence, bronchial hyperreactivity and / or the role of infections influences the risk of developing the disease or its progression.'}, {'measure': 'Comorbidity', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'To characterize the comorbidities associated with GOLD 0 patients and altered diffusion.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD, Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is a multicenter observational prospective study in smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years / pack) with respiratory symptoms and presenting a normal spirometry.\n\nThe patients who sign the corresponding informed consent, will undergo a DLCO and will be divided into two groups according to the result:\n\n* Group I. Patients with DLCO \\<80%.\n* Group II Patients with DLCO≥80%.\n\nBoth groups will be followed for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects over 18 smokers or ex-smokers with cumulative exposure ≥ 10 a / p (years /pack) with respiratory symptoms presenting normal spirometry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years. The participant or his / her legal representative is willing and able to give informed consent to participate in the study.\n* Female or male patients with age equal to or greater than 18 years.\n* Smokers or ex-smokers with cumulative exposure ≥ 10 a / p\n* Respiratory symptoms\n* Normal spirometry.\n\nExclusion Criteria:\n\n* Age under 18 years.\n* Participation in another clinical study.\n* Patients with a life expectancy of less than 2 years due to neoplasms or other serious systemic diseases.\n* Refusal to sing informed consent.'}, 'identificationModule': {'nctId': 'NCT05016466', 'briefTitle': 'GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD (Chronic Obstructive Pulmonary Disease) Screening?', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'GOLD 0 - DLCO 1: A Look Beyond the Obstruction. Is Spirometry Enough for COPD Screening?', 'orgStudyIdInfo': {'id': 'GOLD 0-DLCO 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I. Patients with DLCO <80%.', 'description': 'Patients with DLCO \\<80% will be followed at baseline and once a year during the study', 'interventionNames': ['Other: Standard Care plus oxidative stress study plus inflammation biomarkers study']}, {'label': 'Group II. Patients with DLCO ≥ 80%.', 'description': 'Patients with DLCO ≥80% only will be followed at baseline and year 5.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Standard Care', 'type': 'OTHER', 'description': 'Patients will followed during 5 years, and only 2 visits , baseline and 5 years', 'armGroupLabels': ['Group II. Patients with DLCO ≥ 80%.']}, {'name': 'Standard Care plus oxidative stress study plus inflammation biomarkers study', 'type': 'OTHER', 'description': 'Patients will followed during 5 years, Annual follo-up visits will be carried out during this period', 'armGroupLabels': ['Group I. Patients with DLCO <80%.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'contacts': [{'name': 'cruz Gonzalez, PhD', 'role': 'CONTACT', 'email': 'cruz.gonzalez@uv.es', 'phone': '0034961973977'}], 'facility': 'Hospital Clínico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Cruz González, PhD', 'role': 'CONTACT', 'email': 'cruz.gonzalez@uv.es', 'phone': '0034961973677'}], 'overallOfficials': [{'name': 'Cruz González, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clínico Universitario de Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}