Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT05179850
Status:
UNKNOWN
Last Update Posted:
2022-01-20
First Post:
2021-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computer Aided Diagnostic Tool on Computed Tomography Images for Diagnosis of Retroperitoneal Tumor in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009396', 'term': 'Wilms Tumor'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D013724', 'term': 'Teratoma'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-04', 'studyFirstSubmitDate': '2021-12-16', 'studyFirstSubmitQcDate': '2021-12-16', 'lastUpdatePostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological tumor diagnosis', 'timeFrame': 'Baseline', 'description': 'The diagnosis is defined by histopathological specimens from surgery and/or biopsy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Wilms' Tumor", 'Neuroblastoma', 'Teratoma', 'Lymphoma', 'Sarcoma', 'Germ Cell Tumor']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for retroperitoneal tumor using machine learning and deep learning techniques on computed tomography images in children.', 'detailedDescription': 'The retroperitoneal space extends from the lumbar region to the pelvic region and houses vital structures such as the kidney, the ureter, the adrenal glands, the pancreas, the aorta and its branches, the inferior vena cava and its tributaries, lymph nodes, and loose connective tissue meshwork along with fat. This space thus allows the silent growth of primary and metastatic tumors, such that clinical features appear often too late. The therapeutic regimen differs on various types of retroperitoneal tumor in children. It is damaging for pediatric patients to acquire histological specimens through invasive procedures. Hence, an urgent evaluation is absolutely necessary for preoperative diagnosis in such cases via noninvasive approaches. This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available computed tomography images from June 2010 and December 2020. The investigators have constructed deep learning and machine learning radiomics diagnostic models on this retrospective cohort and validated it internally. A prospective cohort would recruit infantile patients diagnosed as retroperitoneal tumor since January 2021. The proposed deep learning model would also be validated in this prospective cohort externally. The aim of this study was to evaluate the diagnostic efficacy of computer aided diagnostic tool for retroperitoneal tumor using machine learning and deep learning techniques on computed tomography images in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had retroperitoneal tumor and completed the abdominal computed tomography examination before operation, biopsy, neoadjuvant chemotherapy, and radiotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age up to 18 years old\n* Receiving no treatment before diagnosis\n* With written informed consent\n\nExclusion Criteria:\n\n* Clinical data missing\n* Unavailable computed tomography images\n* Without written informed consent'}, 'identificationModule': {'nctId': 'NCT05179850', 'briefTitle': 'Computer Aided Diagnostic Tool on Computed Tomography Images for Diagnosis of Retroperitoneal Tumor in Children', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Computer Aided Diagnostic Tool on Computed Tomography Images for Diagnosis of Retroperitoneal Tumor in Children', 'orgStudyIdInfo': {'id': 'HX-2021477'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective cohort', 'description': 'The internal cohort was retrospectively enrolled in West China Hospital, Sichuan University from June 2010 and December 2020. It is a training and internal validation cohort.', 'interventionNames': ['Diagnostic Test: Radiomic Algorithm']}, {'label': 'Prospective cohort', 'description': 'The same inclusion/exclusion criteria were applied for the same center prospectively. It is a external validation cohort.', 'interventionNames': ['Diagnostic Test: Radiomic Algorithm']}], 'interventions': [{'name': 'Radiomic Algorithm', 'type': 'DIAGNOSTIC_TEST', 'description': 'Different radiomic, machine learning, and deep learning strategies for radiomic features extraction, sorting features and model constriction.', 'armGroupLabels': ['Prospective cohort', 'Retrospective cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6100041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuhan Yang, MD', 'role': 'CONTACT', 'email': 'yyh_1023@163.com', 'phone': '8613258389785'}, {'name': 'Yuhan Yang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Yuhan Yang, MD', 'role': 'CONTACT', 'email': 'yyh_1023@163.com', 'phone': '8613258389785'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yuhan Yang', 'investigatorAffiliation': 'West China Hospital'}}}}