Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-03-15 @ 12:11 PM
Study NCT ID:
NCT04424095
Status:
UNKNOWN
Last Update Posted:
2020-06-09
First Post:
2020-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venous Disease in Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-06', 'studyFirstSubmitDate': '2020-06-06', 'studyFirstSubmitQcDate': '2020-06-06', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Chronic Venous Disease', 'timeFrame': 'at 9 month', 'description': 'The Prevalence of Chronic Venous Disease in the population study will be assessed.'}, {'measure': 'Echo duplex evaluation', 'timeFrame': 'at 10 month', 'description': 'The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic venous disease', 'Pediatrics', 'vein reflux'], 'conditions': ['Chronic Venous Insufficiency', 'Pediatric ALL']}, 'referencesModule': {'references': [{'pmid': '18467617', 'type': 'BACKGROUND', 'citation': 'Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.'}, {'pmid': '15723761', 'type': 'BACKGROUND', 'citation': 'Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.'}, {'pmid': '30505728', 'type': 'BACKGROUND', 'citation': 'Griffiths L, Vasudevan V, Myers A, Morganstern BA, Palmer LS. The role of inheritance in the development of adolescent varicoceles. Transl Androl Urol. 2018 Dec;7(6):920-925. doi: 10.21037/tau.2018.09.02.'}]}, 'descriptionModule': {'briefSummary': 'Chronic venous disease (CVD) is widespread in adult subjects of western countries and is responsible of important morbidity and healthcare costs. CVD has never been extensively studied in pediatric population where the early pathophysiological alterations may occur undetected. The aim of this study is to assess the prevalence of CVD searching also for the early clinical and instrumental signs of this disease.', 'detailedDescription': 'Chronic venous disease (CVD) of lower limbs for its high prevalence in adult population represents one of the main causes of morbidity in western countries, and it has also an important effect on healthcare cost absorbing 1-2% of the total health budget in western countries. Clinical manifestations related to CVD are well documented in adults, with clinical guidelines that standardize both diagnosis and treatment. Nevertheless, there is a scarcity of published data regarding CVD in children, and in addition, venous duplex ultrasound test of the lower limbs is performed much less commonly in children than in adults.\n\nTherefore, the natural history of pediatric venous reflux remains unclear, although it is possible that it precedes the onset of CVD in adulthood. In this context, this observational study aims to identify the presence of venous reflux, as well as clinical and morphological data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular visit and an echo duplex scan of lower limbs. The endpoints of this study are to prospectively assess the prevalence of CVD in children, as well as to evaluate a possible correlation between vein diameter and pathological vein reflux.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric Patients\n\nExclusion Criteria:\n\n* Patients with mental retardation\n* Patients with Marfan syndrome\n* Patients with an inability to stand or collaborate for the clinical tests.'}, 'identificationModule': {'nctId': 'NCT04424095', 'acronym': 'VEDIPEDI', 'briefTitle': 'Venous Disease in Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'University of Catanzaro'}, 'officialTitle': 'Investigation of Chronic Venous Disease in Pediatric Population', 'orgStudyIdInfo': {'id': 'ER.ALL.2018.21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients', 'description': 'Recruited pediatric patients will undergo an in-office vascular visit and an echo duplex scan of lower limbs, in order to detect any symptoms or signs related to chronic venous disease.', 'interventionNames': ['Diagnostic Test: In-office vascular visit', 'Diagnostic Test: Echo Duplex of lower limbs']}], 'interventions': [{'name': 'In-office vascular visit', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)', 'armGroupLabels': ['Pediatric patients']}, {'name': 'Echo Duplex of lower limbs', 'type': 'DIAGNOSTIC_TEST', 'description': 'The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.', 'armGroupLabels': ['Pediatric patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Serra, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'rserra@unicz.it', 'phone': '+3909613647380'}], 'facility': 'University Magna Graecia of Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'centralContacts': [{'name': 'Raffaele Serra, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'rserra@unicz.it', 'phone': '+3909613647380'}], 'overallOfficials': [{'name': 'Raffaele Serra, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Magna Graecia of Catanzaro'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Catanzaro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Vascular Surgery', 'investigatorFullName': 'Prof. Raffaele Serra, MD, Ph.D.', 'investigatorAffiliation': 'University of Catanzaro'}}}}