Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT05194605
Status:
UNKNOWN
Last Update Posted:
2022-01-31
First Post:
2022-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Models of Treatment Responses and Survival Outcomes in Patients With Osteosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-15', 'studyFirstSubmitDate': '2022-01-04', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response', 'timeFrame': 'At least 1-year follow up', 'description': 'The primary outcome was the evaluation of treatment response to individualized therapy in patients with osteosarcoma.'}, {'measure': 'Progression-free survival outcomes', 'timeFrame': 'At least 5-year follow up', 'description': 'The endpoint was defined as the occurrence of progression or recurrence, or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence, or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.'}, {'measure': 'Overall survival outcomes', 'timeFrame': 'At least 5-year follow up', 'description': 'The endpoint was defined as the occurrence of death or the last follow-up. Patients were followed from the day of histological diagnosis until the occurrence of progression or recurrence or last visit. The outcome was evaluated by an experienced oncologist in each center every 3-6 months. At each visit, a medical history, physical examination, and standard laboratory tests were performed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteosarcoma']}, 'descriptionModule': {'briefSummary': "The aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with osteosarcoma and compared these models with currently available models.", 'detailedDescription': 'The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict treatment responses and survival outcomes in patients with biopsy-proven osteosarcoma. Secondly, the investigator aimed to compare the predictive accuracy with currently available noninvasive model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with osteosarcoma who were diagnosed histologically with definite pathologic specimens.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving no treatment before diagnosis\n* With written informed consent\n\nExclusion Criteria:\n\n* Clinical data missing\n* Without written informed consent'}, 'identificationModule': {'nctId': 'NCT05194605', 'briefTitle': 'Predictive Models of Treatment Responses and Survival Outcomes in Patients With Osteosarcoma', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Predictive Models of Treatment Responses and Survival Outcomes in Patients With Osteosarcoma', 'orgStudyIdInfo': {'id': 'HX-20211288'}}, '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': ['Other: Prediction model']}, {'label': 'Prospective cohort', 'description': 'The same inclusion/exclusion criteria were applied for the same center prospectively. It is an external validation cohort.', 'interventionNames': ['Other: Prediction model']}], 'interventions': [{'name': 'Prediction model', 'type': 'OTHER', 'description': 'We develop and validate clinical models to predict treatment responses and survival outcomes in patients with biopsy-proven with osteosarcoma.', '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'}}}}