Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-02 @ 4:24 AM
Study NCT ID:
NCT06815159
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2024-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003956', 'term': 'Dialysis'}], 'ancestors': [{'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery\n\nPOPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to re-intervention for correction of complication and/or new AVF by proximalization,'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-11-28', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.', 'timeFrame': 'From the first patient entrolled, up to the 150th patient, an average of 6 years', 'description': 'Biomarkers of the treated fistula are histologically examined'}], 'secondaryOutcomes': [{'measure': 'Different expression of tissue markers before and during dialysis.', 'timeFrame': 'From the first patient enrolled to the 150th patient, an average of 6 years', 'description': 'Markers expression of the treated tissue are analysed and compared between the two study group.'}, {'measure': 'Markers differences between Basilic and cephalic vein', 'timeFrame': 'From the first patient enrolled, up to the 150th patient, up to 6 years', 'description': 'Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AV Fistula']}, 'descriptionModule': {'briefSummary': 'The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.\n\nPOPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.', 'detailedDescription': "The following study will enroll two cohorts of patients: 75 patients from Population 1 and 75 patients from Population 2, according to the inclusion criteria. Since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early AVF stenosis.\n\nPatients will be treated according to clinical practice in accordance with the physician's judgment.\n\nThe study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the Pathology Department, as part of the normal care pathway, the execution of three tissue samples at the Pathology Department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°C for RT-PCR analysis; (ii) a sample placed in PBS for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and IIC investigations; execution of cell culture investigations and execution of RT-PCR investigations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years;\n* Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;\n* Obtaining informed consent signed by the patient\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT06815159', 'acronym': 'FAV-2019', 'briefTitle': 'Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis', 'orgStudyIdInfo': {'id': 'FAV-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First FAV', 'description': 'Group of patient with first FAV', 'interventionNames': ['Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.']}, {'type': 'EXPERIMENTAL', 'label': 'Secondary FAV', 'description': 'Group of patients with reintervention of FAV', 'interventionNames': ['Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.']}], 'interventions': [{'name': 'Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.', 'type': 'BIOLOGICAL', 'description': 'Primary objective\n\n1. Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.\n\n Secondary objectives\n2. Compare the results on the possible different expression of tissue markers before and during dialysis.\n3. Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.', 'armGroupLabels': ['First FAV', 'Secondary FAV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mauro Prof Gargiulo, MD', 'role': 'CONTACT', 'email': 'mauro.gargiulo2@unibo.it', 'phone': '0512143288'}], 'facility': "IRCCS AOU di Bologna Policlinico di Sant'Orsola", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Mauro Gargiulo, MD', 'role': 'CONTACT', 'email': 'mauro.gargiulo2@unibo.it', 'phone': '0512143288'}], 'overallOfficials': [{'name': 'Mauro Gargiulo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}