Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 4:23 AM
Study NCT ID:
NCT04551235
Status:
UNKNOWN
Last Update Posted:
2022-03-10
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the accuracy of cell counting and classifying between automatic method and manual method through digital microscopic photos of bone marrow smear and peripheral blood smear using deep convolutional neural networks', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematologic Diseases', 'Artificial Intelligence', 'Acute Leukemia']}, 'descriptionModule': {'briefSummary': 'Counting and classification of blood cells in a bone marrow smear and peripheral blood smear are essential to clinical hematology. To this date, this procedure has been carried out in a manual manner in the great majority of clinical settings. There is often inconsistency in the counting result between different operators largely due to its manual nature. There has not been an effective and standard method for blood smear preparation and automatic counting and classification. The recent advent of deep neural network for medical image processing introduced new opportunities for an effective solution of this long-standing problem. Numerous results have been published on the effectiveness of convolutional neural network in clinical image recognition task.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have suspected or confirmed hematological diseases and receive bone marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have suspected or confirmed hematological diseases and receive bone\n* marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center\n* Patients who are aged more than 20 y/o\n\nExclusion Criteria:\n\n•Patients who are not willing to sign informed consents'}, 'identificationModule': {'nctId': 'NCT04551235', 'briefTitle': 'Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells', 'orgStudyIdInfo': {'id': '202007086RIPB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'there are not any interventions in this study', 'type': 'OTHER', 'description': 'there are not any interventions in this study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Bor-Sheng Ko', 'role': 'CONTACT', 'email': 'kevinkomd@gmail.com', 'phone': '886-9-726512'}], 'facility': 'National Taiwan University Tai-Chen Cell Therapy Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Bor-Sheng Ko', 'role': 'CONTACT', 'email': 'kevinkomd@gmail.com', 'phone': '886-0-72651297'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University Tai-Chen Cell Therapy Center, Biomdcare Corporation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}