Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT05100368
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012512', 'term': 'Sarcoma, Ewing'}], 'ancestors': [{'id': 'D012516', 'term': 'Osteosarcoma'}, {'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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2021-10-18', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year survival', 'timeFrame': 'at baseline (Day0)', 'description': 'Evaluation of 5-year survival in relation to histologic, laboratory, clinical, and instrumental laboratory, clinical and instrumental factors'}], 'secondaryOutcomes': [{'measure': 'Rate of local recurrence', 'timeFrame': 'at baseline (Day0)', 'description': 'Evaluation of the rate of local recurrence and distant metastasis in relation to prognostic factors histological, laboratory, clinical and instrumental factors;'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcoma; ewing'], 'conditions': ['Sarcoma, Ewing']}, 'referencesModule': {'references': [{'pmid': '23450030', 'type': 'RESULT', 'citation': 'Nakamura T, Grimer RJ, Gaston CL, Watanuki M, Sudo A, Jeys L. The prognostic value of the serum level of C-reactive protein for the survival of patients with a primary sarcoma of bone. Bone Joint J. 2013 Mar;95-B(3):411-8. doi: 10.1302/0301-620X.95B3.30344.'}, {'pmid': '29033609', 'type': 'RESULT', 'citation': 'Li YJ, Yang X, Zhang WB, Yi C, Wang F, Li P. Clinical implications of six inflammatory biomarkers as prognostic indicators in Ewing sarcoma. Cancer Manag Res. 2017 Sep 28;9:443-451. doi: 10.2147/CMAR.S146827. eCollection 2017.'}, {'pmid': '27567955', 'type': 'RESULT', 'citation': 'Aggerholm-Pedersen N, Maretty-Kongstad K, Keller J, Baerentzen S, Safwat A. The Prognostic Value of Serum Biomarkers in Localized Bone Sarcoma. Transl Oncol. 2016 Aug;9(4):322-8. doi: 10.1016/j.tranon.2016.05.006.'}]}, 'descriptionModule': {'briefSummary': "Extraction of laboratory data from blood tests prior to surgical and chemotherapy and other histological, clinical and instrumental data related to the patient's history from the digitized medical Digitized medical records and analysis of the same. The medical records of 1000 patients from January 1, 2000, until December 31, 2020"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Ewing's sarcoma or osteosarcoma", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis;\n* Patients with age ≥ 2 years;\n* Minimum follow-up duration of 2 years;\n* Medical records, complete blood work and instrumental examinations; Regular follow-up.\n\nExclusion Criteria:\n\n* Patients with Ewing's sarcoma or osteosarcoma who have received medical treatment (surgery radiotherapy or chemotherapy) in other institutions prior to admission to the Rizzoli Orthopaedic Institute."}, 'identificationModule': {'nctId': 'NCT05100368', 'briefTitle': "The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma", 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': "The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma", 'orgStudyIdInfo': {'id': 'PROSARC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': "Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis", 'interventionNames': ['Other: patients']}], 'interventions': [{'name': 'patients', 'type': 'OTHER', 'description': "Patients with Ewing's Sarcoma and osteosarcoma with established diagnosis", 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Costantino Errani', 'investigatorAffiliation': 'Istituto Ortopedico Rizzoli'}}}}