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Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project

Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05357768
Acronym
GRACefUl
Enrollment
260
Registered
2022-05-03
Start date
2019-06-11
Completion date
2028-12-31
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undifferentiated Round Cell Sarcoma

Brief summary

Experimental study with biological material : case series review of clinical and histological data

Detailed description

This is a multicenter retrospective and prospective study that will analyze all cases with a diagnosis of Undifferentiated round cell sarcomas from 01 January 1983 and all new cases referring to each participant site.

Interventions

OTHERdata 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.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL

Inclusion criteria

* Patients with undifferentiated round cell sarcomas treated from 01 January 1983 and all new patients will be included. * 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

* Diagnosis different from undifferentiated round cell sarcomas * Patient with no clinical or outcome information available

Design outcomes

Primary

MeasureTime frameDescription
event free survivalbaselineCorrelate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas.

Countries

Italy

Contacts

Primary ContactEmanuela Palmerini, MD
emanuela.palmerini@ior.it051.63.66
Backup ContactMarco Gambarotti, MD
marco.gambarotti@ior.it051.63.66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026