Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT05942456
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soluble B7-H3 as a Biomarker for Osteosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-11', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-05', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of quantity of Protein B7-H3 Expression with clinical evaluation', 'timeFrame': '6 months', 'description': 'Clinical evaluation according to RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'correlation of quantity of Protein B7-H3 Expression with histological responses', 'timeFrame': '6 months', 'description': 'Histological responses according to Huvos Grade'}, {'measure': 'correlation of quantity of Protein B7-H3 Expression with event-free survival', 'timeFrame': '2 years', 'description': 'event-free survival calculated from starting systemic therapy to any tumor-related events for progression'}, {'measure': 'correlation of quantity of Protein B7-H3 Expression with overall survival', 'timeFrame': '5 years', 'description': 'overall survival calculated from starting systemic therapy to death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sB7-H3', 'osteosarcoma', 'biomarker', 'prognosis', 'clinical evaluation'], 'conditions': ['Biomarker', 'Progression', 'Osteosarcoma', 'Surveillance']}, 'referencesModule': {'references': [{'pmid': '30123093', 'type': 'BACKGROUND', 'citation': 'Wang L, Kang FB, Zhang GC, Wang J, Xie MF, Zhang YZ. Clinical significance of serum soluble B7-H3 in patients with osteosarcoma. Cancer Cell Int. 2018 Aug 13;18:115. doi: 10.1186/s12935-018-0614-z. eCollection 2018.'}, {'pmid': '36519392', 'type': 'BACKGROUND', 'citation': 'Xie L, Chen C, Liang X, Xu J, Sun X, Sun K, Yang R, Tang X, Guo W. Expression and Clinical Significance of Various Checkpoint Molecules in Advanced Osteosarcoma: Possibilities for Novel Immunotherapy. Orthop Surg. 2023 Mar;15(3):829-838. doi: 10.1111/os.13620. Epub 2022 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'Increasing data has indicated an association between increased soluble B7-H3 (sB7-H3) levels and unfavorable prognosis in patients with malignancies. However, the level of sB7-H3 and its clinical significance in osteosarcoma are not well known. In this present study, we investigated whether sB7-H3 levels in serum could be as a biomarker for osteosarcoma treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* High Grade osteosarcoma verified with pathologic diagnosis.\n* systemic treatment-naive before the first time Blood drawing.\n* ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy.\n* All radiographs are complete for clinical evaluation.\n\nExclusion Criteria:\n\n* Patients who Can't tolerate blood drawing.\n* Patients without complete medical records in PKUPH system.\n* Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy.\n* other conditions that investigators think are not suitable for this study."}, 'identificationModule': {'nctId': 'NCT05942456', 'briefTitle': 'Soluble B7-H3 as a Biomarker for Osteosarcoma', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'An Exploratory Research of Soluble B7-H3 Expression in Peripheral Blood as a Biomarker to Monitor Therapeutic Effect of Systemic Treatment for Osteosarcoma', 'orgStudyIdInfo': {'id': 'PKUPH-sarcoma 16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'sB7-H3 of treatment-naive osteosarcoma patients', 'description': 'Before delivering neoadjuvant chemotherapy, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood', 'interventionNames': ['Diagnostic Test: ELISA: enzyme-linked immunosorbent assay']}, {'label': 'sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients', 'description': 'After neoadjuvant chemotherapy and before definitive surgery, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood', 'interventionNames': ['Diagnostic Test: ELISA: enzyme-linked immunosorbent assay']}], 'interventions': [{'name': 'ELISA: enzyme-linked immunosorbent assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'enzyme-linked immunosorbent assay', 'armGroupLabels': ['sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients', 'sB7-H3 of treatment-naive osteosarcoma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Xie, M.D.', 'role': 'CONTACT', 'email': 'xie.lu@hotmail.com', 'phone': '+86-13401044719'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lu Xie, M.D.', 'role': 'CONTACT', 'email': 'xie.lu@hotmail.com', 'phone': '+86-13401044719'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Musculoskeletal Tumor Center', 'investigatorFullName': 'Xie Lu', 'investigatorAffiliation': "Peking University People's Hospital"}}}}