Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT07137351
Status:
WITHDRAWN
Last Update Posted:
2025-08-22
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Biosensor Using the Target Urine VOCs for Detecting DKD Diabetic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D009404', 'term': 'Nephrotic Syndrome'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009401', 'term': 'Nephrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This record was initially withdrawn due to incomplete protocol section. The study was completed and published, and a corrected version will be submitted under a new record', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristic of VOCs in DKD', 'timeFrame': 'March 2024- July 2024', 'description': 'Electrical resistance characteristic VOCs by semiconductors in DKD when compared to normal and NS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VOCs', 'Biosensor', 'diabetic kidney disease', 'nephrotic syndrome'], 'conditions': ['Urine VOCs From DKD and Nephrotic Syndrome Pateints']}, 'descriptionModule': {'briefSummary': 'Volatile organic compounds (VOCs) are easily evaporated substances produced by pathophysiologic metabolism and have been utilized in research as potential new biomarkers for differentiating various diseases, acting as the odor imprints of each disease.\n\nResearchers used metal oxide semiconductors to examine the properties of VOCs produced by diabetic kidney disease patients. Also, the VOCs of those with diabetic kidney disease were then compared with those of healthy individuals and patients with nephrotic syndrome.\n\nThe study found that VOCs primarily composed of hydrogen, methanol, and sulfate in diabetic kidney disease patients had a significantly different ability to release free electrons from the metal oxide semiconductors compared to healthy individuals and patients with nephrotic syndrome from other causes. This finding suggested that VOCs could be used as biomarkers which could lead to the replacement of renal biopsy for diagnosis in the future.', 'detailedDescription': 'This study was a descriptive cohort study. General data such as age, gender, medications, other medical conditions, or chronic diseases that might have affected the urine VOCs test were reviewed and recorded from the medical records of subjects who attended the outpatient clinic of the Internal Medicine department at the Suranaree University of Technology Hospital from March 2024 to July 2024. Urine samples from diabetic patients, both with and without abnormal proteinuria, were compared with normal urine samples and urine samples from patients with NS from other causes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study was a descriptive cohort study. General data such as age, gender, medications, other medical conditions, or chronic diseases that might have affected the urine VOCs test were reviewed and recorded from the medical records of subjects who attended the outpatient clinic of the Internal Medicine department at the Suranaree University of Technology Hospital from March 2024 to July 2024. Urine samples from diabetic patients, both with and without abnormal proteinuria, were compared with normal urine samples and urine samples from patients with NS from other causes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 20 years\n* In DKD and NS groups must undergone renal biopsy before study\n\nExclusion Criteria:\n\n* Patients with an estimated glomerular filtration rate (eGFR) \\< 15 mL/min/1.73 m2\n* Pregnancy\n* Ambiguous pathological results'}, 'identificationModule': {'nctId': 'NCT07137351', 'acronym': 'VOCs in DKD', 'briefTitle': 'The Biosensor Using the Target Urine VOCs for Detecting DKD Diabetic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Suranaree University of Technology'}, 'officialTitle': 'The Biosensor Using the Target Urine Volatile Organic Compounds for Detecting Diabetic Kidney Disease', 'orgStudyIdInfo': {'id': 'EC-67-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3', 'description': '็Healthy volunteer, DKD pateints, other causes of Nephrotic syndrome', 'interventionNames': ['Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds']}, {'label': '็Healthy volunteer', 'description': '็Healthy volunteer = normal subject or diabetes pateint without proteinuria (\\< 300 mg/day)', 'interventionNames': ['Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds']}, {'label': 'DKD pateints', 'description': 'DKD = diabetic kidney disease with proteinuria (\\> 1 g/day) with confirmed by pathological results', 'interventionNames': ['Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds']}, {'label': 'other causes of Nephrotic syndome', 'description': 'NS = other casues of nephrotic syndrome, pateints must have with proteinuria \\> 3.5 g/day) with confirmed by pathological results. In addition, They must have no DM in the illness profile.', 'interventionNames': ['Diagnostic Test: The Biosensor Using the Target Urine Volatile Organic Compounds']}], 'interventions': [{'name': 'The Biosensor Using the Target Urine Volatile Organic Compounds', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Metal oxide semiconductor detecting VOCs'], 'description': 'The authors opted to utilize five distinct commercially available semiconductors (metal oxide sensors) to detect all the targeted VOCs which were manufactured by Figaro company.\n\nUrine samples from patients were placed in a urine container, which was then placed into the VOCs detection device. The lid was closed, and the system was set to operate in a closed-loop mode at a room temperature of 25 degrees Celsius. The device then vacuumed VOCs from the urine samples of the patients through a gas tube into the biosensor chamber located on top, where analysis was performed.', 'armGroupLabels': ['3', 'DKD pateints', 'other causes of Nephrotic syndome', '็Healthy volunteer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30000', 'city': 'Nakhon Ratchasima', 'country': 'Thailand', 'facility': 'Institute of Medicine, Suranaree University of Technology', 'geoPoint': {'lat': 14.97066, 'lon': 102.10196}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the urine samples were indentided by some special code and not allowed to share with other researches.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suranaree University of Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Dr. Chatchai Kreepala, M.D.', 'investigatorFullName': 'Chatchai Kreepala, MD', 'investigatorAffiliation': 'Suranaree University of Technology'}}}}