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

Recruiting

• Conditions: Undifferentiated Round Cell Sarcoma
• Interventions: Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue

• Registration Number: NCT05357768
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2019-06-11
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
retrospective cohort	data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue	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.
prospective cohort	data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue	prospective patients with undifferentiated round cell sarcomas will be included in the study. For prospective study, it is expect to include 60 patients.

Primary Outcome Measures

Name	Time	Method
event free survival	baseline	Correlate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas.

Trial Locations

Locations (1)

IRCCs Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy