Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-11 @ 4:18 AM
Study NCT ID:
NCT03270358
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2017-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OStéopontin as a Marker Of StenoSIS - OSMOSIS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D003250', 'term': 'Constriction'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasmatic osteopontin level', 'timeFrame': 'at inclusion', 'description': "Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.\n\n* Control arm: right before a dialysis session\n* Experimental arm: right before the surgery for stenosis of the fistula"}], 'secondaryOutcomes': [{'measure': 'Peripheral plasmatic osteopontin level in the contralateral arm', 'timeFrame': 'at inclusion', 'description': 'Peripheral plasmatic osteopontin level (ng/ml) collected in the contralateral arm (to measure the potential bias of a local osteopontin production in the fistula)'}, {'measure': 'Peripheral plasmatic osteopontin level in the contralateral arm', 'timeFrame': 'at inclusion', 'description': 'Measure of the plasmatic osteopontin specificity and sensibility on the occurrence of a fistula stenosis (differents tresholds)'}, {'measure': 'Peripheral plasmatic osteopontin level in the contralateral arm', 'timeFrame': 'at inclusion', 'description': "Collection of comorbidity factors (diabetes, arterial hypertension, coronaropathy, overweight (BMI)), clinical factors (age and gender) and treatments at the time of patient's inclusion (anticoagulant, antisludge, antihypertensive drug, statins, erythropoietin)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stenosis']}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was correlated with coronary stent restenosis, and with cardiovascular outcome in patients with diabetes and renal insufficiency. This protein is secreted by several cellular types, like distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing immunological mechanisms as well as tissue remodeling.\n\nThe main objective of this study is to show that the amount of plasma OPN is higher in patients presenting with an AVF stenosis, compared with patients with a functioning AVF.\n\nOSMOSIS is a monocentric pilot study that will include patients into two groups during 12 months (no specific follow-up). The control group will include patients that have been dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months without any incident. The experimental group will include hemodialysis patients hospitalized in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open surgical revision for venous stenosis.\n\nBlood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me measured by ELISA. Their clinical data would be collected from medical file at the same time. After the procedure, patients will be followed-up according to usual protocols.\n\nTo show a significant difference of 100ng/mL plasma OPN between the two groups, with a power of 90% and alpha risk of 0.05, we plan to include 76 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under a social security scheme\n* Written informed consent obtain\n* 18 years old or older\n* end-stage renal failure disease with 3 months dialysis minimum on a native arteriovenous fistula\n\nNon-inclusion Criteria:\n\n* Subject under juridicial protection\n* Pregnant or lactating women\n* Subject already enrolled in a clinical trial involving a drug or an implantable medical device\n\nExclusion Criteria:\n\n* Withdrawal of consent\n* Investigator or sponsor decision'}, 'identificationModule': {'nctId': 'NCT03270358', 'acronym': 'OSMOSIS', 'briefTitle': 'OStéopontin as a Marker Of StenoSIS - OSMOSIS', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'OStéopontin as a Marker Of StenoSIS - OSMOSIS', 'orgStudyIdInfo': {'id': '17-AOI-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patient with stenosis', 'description': 'Patient coming to the vascular surgery unit to receive surgery regarding their fistula stenosis', 'interventionNames': ['Procedure: Blood sampling in arterioveinous fistula with stenosis']}, {'type': 'OTHER', 'label': 'patient without stenosis', 'description': 'Patient coming for their dialysis', 'interventionNames': ['Procedure: Blood sampling in arterioveinous fistula without stenosis']}], 'interventions': [{'name': 'Blood sampling in arterioveinous fistula without stenosis', 'type': 'PROCEDURE', 'description': "Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.\n\nBlood sampling in arterioveinous fistula right before a dialysis session", 'armGroupLabels': ['patient without stenosis']}, {'name': 'Blood sampling in arterioveinous fistula with stenosis', 'type': 'PROCEDURE', 'description': 'Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula', 'armGroupLabels': ['patient with stenosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice - Service de chirurgie vasculaire', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Nirvana SADAGHIANLOO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sadaghianloo.n@chu-nice.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}