Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:08 PM
Study NCT ID:
NCT07474220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expression of SLC25A48 in Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'Peripheral venous blood samples will be collected. Plasma, isolated peripheral blood mononuclear cells will be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'expression of SLC25A48', 'timeFrame': 'one day', 'description': 'the expression level of SLC25A48 in mitochondria isolated from peripheral blood mononuclear cells'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease', 'Mitochondrial choline transport', 'SLC25A48', 'Inflammatory markers', 'Choline metabolism'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the expression level of SLC25A48, a mitochondrial choline transporter, in peripheral blood mononuclear cells of patients with chronic obstructive pulmonary disease, and to analyze its correlation with inflammatory markers and choline metabolic byproducts.', 'detailedDescription': 'Background:\n\nChronic obstructive pulmonary disease is the third leading cause of death worldwide, characterized by airflow limitation, alveolar damage, and chronic systemic inflammation. These features are closely associated with malnutrition, muscle loss, and oxidative stress. Mitochondrial dysfunction plays a critical role in immune dysregulation, with peripheral blood mononuclear cells widely used in studies on inflammation and metabolism. Choline, essential for one-carbon metabolism and immune function, requires specific transporters to enter mitochondria. SLC25A48, a newly identified mitochondrial choline transporter, is linked to impaired choline uptake, elevated reactive oxygen species, and metabolic imbalance. However, its role in chronic obstructive pulmonary disease remains unclear.\n\nStudy Design:\n\nThis multicenter, prospective observational study\n\nMethods:\n\nThe expression of SLC25A48 in peripheral blood mononuclear cells will be quantified and analyzed in relation to inflammatory markers and choline metabolism indicators. All participants will undergo pulmonary function testing, nutritional and quality of life assessments, and blood biochemistry. Peripheral blood mononuclear cells will be isolated using density gradient centrifugation, followed by protein extraction and quantification via Western blot and image-based analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient of hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines (case group)\n* healthy individuals without chronic diseases or major medical conditions\n\nExclusion Criteria:\n\n* diagnosed with neuromuscular diseases\n* experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months\n* assessed by a physician to have severe malnutrition or a significantly low BMI\n* continuously taking folic acid supplements\n* willing to receive or have already received self-paid nutrition clinic services at this hospital'}, 'identificationModule': {'nctId': 'NCT07474220', 'briefTitle': 'Expression of SLC25A48 in Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Fu Jen Catholic University'}, 'officialTitle': 'Association Between SLC25A48 Expression and Chronic Obstructive Pulmonary Disease Progression', 'orgStudyIdInfo': {'id': 'FJUH114470'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'Pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines'}, {'label': 'Control group', 'description': 'healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23148', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.con', 'phone': '+886-905-301-879'}], 'facility': 'Cardinal Tien Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '24352', 'city': 'New Taipei City', 'country': 'Taiwan', 'contacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.con', 'phone': '+886-905-301-879'}], 'facility': 'Fu Jen Catholic University Hospital, Fu Jen Catholic University', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'centralContacts': [{'name': 'Ke-Yun Chao, PhD', 'role': 'CONTACT', 'email': 'ck_qq@hotmail.com', 'phone': '+886-905-301-879'}], 'overallOfficials': [{'name': 'Ke-Yun Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fu Jen Catholic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fu Jen Catholic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ke-Yun, Chao', 'investigatorAffiliation': 'Fu Jen Catholic University'}}}}