Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-01 @ 3:51 PM
Study NCT ID:
NCT05155267
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2021-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': '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_WITH_DNA', 'description': 'Blood, urine and feces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2021-11-30', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomonitoring study to detect the presence of MNPLs in biological fluids', 'timeFrame': 'Up to 1 year', 'description': 'Micro and nanoplastic and/or derivatives, would be evaluated. Characterization of possible biomarkers of early biological effects on human health'}, {'measure': 'Study of the effects of MNPLs on immune system', 'timeFrame': 'Up to 1 year', 'description': 'Impact evaluation of MNPLs on transcriptome, secretome and inflammatory signalling and inflammasome activation. Investigating the effect of MNPLs on the function of the immune system in vivo and in high-risk individuals'}, {'measure': 'Genotoxicity effects of exposure to MNPLs', 'timeFrame': 'Up to 1 year', 'description': 'Genotoxic, chromosome damage evaluation and oxidative DNA damage will be analysed by the Comet assay and the micronucleus assay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD', 'MNPLs'], 'conditions': ['Chronic Kidney Diseases', 'Microplastics', 'Nanoplastics', 'Genotoxic Damage']}, 'descriptionModule': {'briefSummary': 'Micro and nanoplastics (MNPLs) effects on human heath is still preliminary. Chronic kidney disease (CKD) participants, specially does patients submitted to hemodialysis, are a population high exposed to plastics. The objective of our research is to be able to detect MNPLs on biological fluids of hemodialysis patients as well as their potential genotoxic and immunological damage.', 'detailedDescription': "The exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic-waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on the MNPLs' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate human exposure/risk assessment.\n\nThe study aims to analyse specific biomarkers of exposure to MNPLs in humans, as well as biomarkers of genetic damage, which will allow an association between exposure to these plastic materials and the optimisation of different techniques for the detection and characterisation of MNPLs.\n\nThe study will evaluate the effect of exposure to MNPLs, analysing the genotoxic damage, different biomarkers of exposure and the effects on microbiota, in different body samples (urine, blood and feces)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This project will study a minimum of 25 adult participants with chronic kidney disease, included and not included in an haemodialysis programme. A control group (at least 25 individuals), matched by gender, age and lifestyle with CKD participants will be also included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Chronic Kidney Disease (CKD) submitted to Hemodialysis:\n\n* Participant submitted to hemodialysis for more than 3 months\n* Between 18 and 85 years old\n* Stable haemoglobin (more than 10 gr/dl)\n* Absence of infectious disease at the date of sample collection and for a period of more than two weeks\n* Absence of active neoplasia\n* Stable vascular access\n\nInclusion Criteria for Chronic Kidney Disease (CKD) pre-dialysis:\n\n* No hemodialysis treatment\n* Between 18 and 85 years old\n* Stable haemoglobin (more than 10 gr/dl)\n* Glomerular filtration ≤ 20 ml/min\n* Absence of infectious disease at the date of sample collection and for a period of more than two weeks\n* Absence of active neoplasia\n\nInclusion Criteria for controls :\n\n* Between 18 and 85 years old (paired by gender, age and lifestyle to the CKD patients)\n* Absence of chronic kidney disease or dialysis treatment\n* Absence of chronic pathology (including neoplasia)\n* Absence of infectious disease at the date of sample collection and for a period of more than two weeks\n* Spanish residence\n\nExclusion Criteria for both groups of CKD patients:\n\n* Clinical instability\n* Life expectancy of less than 12 months\n* Coagulation system disorders\n* Participation in other clinical study\n* Pregnancy\n* Unsigned informed consent\n\nExclusion criteria for controls:\n\n* Participation in other clinical study\n* Pregnancy\n* Unsigned informed consent'}, 'identificationModule': {'nctId': 'NCT05155267', 'briefTitle': 'Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Autonoma de Barcelona'}, 'officialTitle': 'Biomonitoring of Internal Exposure to MNPLs (Micro and NanoPlastics), and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)', 'orgStudyIdInfo': {'id': '1-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Kidney disease participants (CKD)_HD', 'description': 'CKD submitted to hemodialysis (HD)', 'interventionNames': ['Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects']}, {'label': 'Chronic Kidney disease participants (CKD)_PD', 'description': 'CKD non-submitted to hemodialysis (pre-dialysis:PD)', 'interventionNames': ['Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects']}, {'label': 'Controls', 'description': 'Healthy participants', 'interventionNames': ['Other: Biomonitoring study to detect MNPLs in biological samples and study of their health effects']}], 'interventions': [{'name': 'Biomonitoring study to detect MNPLs in biological samples and study of their health effects', 'type': 'OTHER', 'description': 'Determination of MNPLs levels, genotoxic damage and immunological effects', 'armGroupLabels': ['Chronic Kidney disease participants (CKD)_HD', 'Chronic Kidney disease participants (CKD)_PD', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Laura Martinez, Dr.', 'role': 'CONTACT', 'email': 'lma5@um.es'}], 'facility': 'Servicio Murciano de Salud', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}], 'centralContacts': [{'name': 'Ricard Marcos', 'role': 'CONTACT', 'email': 'ricard.marcos@uab.cat', 'phone': '+34 93 586 20 52'}], 'overallOfficials': [{'name': 'Pablo Pelegrín', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Murciano de Investigación Biosanitaria (IMIB)'}, {'name': 'Juan Bernardo Cabezuelo', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clínico Universitario Virgen Arrixaca (Murcia)'}, {'name': 'Laura Martínez', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clínico Universitario Virgen Arrixaca (Murcia)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ricard Marcos', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca', 'class': 'OTHER'}, {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ricard Marcos', 'investigatorAffiliation': 'Universitat Autonoma de Barcelona'}}}}