Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project
NCT ID: NCT05357768
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
260 participants
OBSERVATIONAL
2019-06-11
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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retrospective cohort
Patients with undifferentiated round cell sarcomas treated from 01 January 1983 to April 2019 will be included.
For retrospective analysis, it is expected to include about 200 patients.
data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue
Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue of cases negative for all Ewing's sarcoma molecular fusions, will be analyzed for the presence of CIC-DUX4 / BCOR-CCNB3 translocations fusion at each Institution.
Treatment, outcome, and prognostic factors will be related with the molecular re-classification.
prospective cohort
prospective patients with undifferentiated round cell sarcomas will be included in the study. For prospective study, it is expect to include 60 patients.
data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue
Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue of cases negative for all Ewing's sarcoma molecular fusions, will be analyzed for the presence of CIC-DUX4 / BCOR-CCNB3 translocations fusion at each Institution.
Treatment, outcome, and prognostic factors will be related with the molecular re-classification.
Interventions
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data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue
Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue of cases negative for all Ewing's sarcoma molecular fusions, will be analyzed for the presence of CIC-DUX4 / BCOR-CCNB3 translocations fusion at each Institution.
Treatment, outcome, and prognostic factors will be related with the molecular re-classification.
Eligibility Criteria
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Inclusion Criteria
* Clinical and outcome information available.
* Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis/frozen tissue representative of the tumor available.
Exclusion Criteria
* Patient with no clinical or outcome information available
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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IRCCs Istituto Ortopedico Rizzoli
Bologna, BO, Italy
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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GRACefUl
Identifier Type: -
Identifier Source: org_study_id
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