Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 8:50 PM
Study NCT ID:
NCT06662734
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005354', 'term': 'Fibrosarcoma'}], 'ancestors': [{'id': 'D018218', 'term': 'Neoplasms, Fibrous 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': 12783}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-25', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The standardized incidence ratio and excess risk of developing multiple primary malignancies following fibrosarcoma diagnosis', 'timeFrame': 'from Jan, 2000 till Dec, 2021', 'description': 'The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the Excess absolute risk for Multiple primary malignancies for fibrosarcoma patients'}, {'measure': 'The standardized incidence ratio and excess risk of developing second primary malignancies for different subtypes of fibrosarcoma', 'timeFrame': 'from Jan, 2000 till Dec, 2021'}], 'secondaryOutcomes': [{'measure': 'The standardized incidence ratio and excess risk of multiple primary malignancies in fibrosarcoma patients across different racial groups', 'timeFrame': 'from Jan, 2000 till Dec, 2021'}, {'measure': 'The standardized incidence ratio and excess risk of multiple primary malignancies in both males and females in fibrosarcoma patients', 'timeFrame': 'from Jan, 2000 till Dec, 2021'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infantile fibrosarcoma', 'Fibrosarcoma', 'SEER'], 'conditions': ['Fibrosarcoma']}, 'descriptionModule': {'briefSummary': 'Fibrosarcoma is a malignant tumor originating from mesenchymal tissues and consists of fibroblasts with various types of collagen production. It represents 10% of musculoskeletal sarcomas and less than 5% of all primary bone tumors. It affects middle-aged patients with the most common location in the femur and 70% long tubular bones. Studies reported that fibrosarcoma patients tend to develop a subsequent primary malignancy, the analysis showed a higher risk of SPMs even a decade following the initial diagnosis of fibrosarcoma.\n\nSPMs affect the long-term survival of patients with soft tissue tumors, and since there are no available studies analyzing the risk of second primary malignancies in different types of fibrosarcomas, especially the infantile and adult-type. Therefore, the purpose of this study was to assess the risk of second primary malignancies following primary fibrosarcoma diagnosis for a better understanding of the nature of this rare neoplasm. The investigators used the Surveillance, Epidemiology and End Results (SEER) database to extract the data and calculate the standardized incidence ratio as Observed/Expected and the Excess risk for second primary malignancies with 95% Confidence Interval. Significance was achieved at 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 12,783 patients diagnosed with fibrosarcoma between 2000 and 2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with fibrosarcoma from 2000 to 2021.\n* Sequence 0 or 1.\n* Histological types:\n\nInfantile fibrosarcoma, Fibromyxosarcoma, Periosteal fibrosarcoma, Facial fibrosarcoma, Dermatofibrosarcoma, Central odontogenic fibrosarcoma, Ameloblastic fibrosarcoma\n\nExclusion Criteria:\n\n* Patients with unknown histology type'}, 'identificationModule': {'nctId': 'NCT06662734', 'briefTitle': 'Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Suez Canal University'}, 'officialTitle': 'Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies: a Retrospective Cohort Based on SEER Database', 'orgStudyIdInfo': {'id': 'A274'}}, 'contactsLocationsModule': {'locations': [{'zip': '41512', 'city': 'Ismailia', 'country': 'Egypt', 'facility': 'Suez Canal University', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'asmaa salama ibrahim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Resident physician of gastroenterology', 'investigatorFullName': 'asmaa salama ibrahim', 'investigatorAffiliation': 'Suez Canal University'}}}}