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Recruiting NCT05357768

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

Observational Undifferentiated Round Cell Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue.
Who it may be relevant to
Registry conditions: Undifferentiated Round Cell Sarcoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other 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.

Primary outcome measures

  • event free survival [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Other

Study locations

Italy · 1 center
  • IRCCs Istituto Ortopedico Rizzoli — Bologna

Identifiers

NCT: NCT05357768 · GRACefUl

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗