Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-30 @ 7:33 AM
Study NCT ID:
NCT06084650
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography (OCT) and OCT Angiography(OCTA) Deep Learning in Waldenström's Macroglobulinemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'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': 'ACTUAL', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurements of retinal and choriocapillary vessel density in Waldenstrom Macroglobulinemia patients.', 'timeFrame': 'up to three months', 'description': 'The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Waldenstrom Macroglobulinemia']}, 'descriptionModule': {'briefSummary': "This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in Waldenström's Macroglobulinemia patients, using optical coherence tomography angiography.", 'detailedDescription': 'Waldenstrom macroglobulinemia (mak-roe-glob-u-lih-NEE-me-uh) is a rare type of cancer that begins in the white blood cells.\n\nThe optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in Waldenstrom macroglobulinemia, elaborating these data with artificial intelligence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participans were older than 18 years with diagnosis of Waldenstrom Macroglobulinemia. They did not present other ophthalmological disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 18 years\n\n * diagnosis of Waldenstrom Macroglobulinemia\n * absence of previous ocular surgery and congenital eye diseases.\n * absence of errors of refraction\n * absence of lens opacities\n * absence of low-quality OCT and OCTA images\n\nExclusion Criteria:\n\n* • age younger than 18 years\n\n * previous ocular surgery and congenital eye diseases\n * errors of refraction\n * lens opacities\n * low-quality OCT and OCTA images'}, 'identificationModule': {'nctId': 'NCT06084650', 'acronym': 'OCTA', 'briefTitle': "Optical Coherence Tomography (OCT) and OCT Angiography(OCTA) Deep Learning in Waldenström's Macroglobulinemia Patients", 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': "OCT and OCTA Deep Learning in Waldenström's Macroglobulinemia Patients", 'orgStudyIdInfo': {'id': '05809851'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'waldenstrom macroglobulinemia patients'}, {'label': 'healthy patients matched age and sex without waldenstrom macroglobulinemia and ocular disease'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Napoli', 'country': 'Italy', 'facility': 'University of Naples "Federico II" Naples, Italy, 80100 Contact: Gilda Cennamo, MD 00390817143731 xgilda@hotmail.com', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}