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NCT Number: NCT05357768

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

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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCs Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location status: Recruiting

Location contact

Emanuela Palmerini, MD

CONTACT

[email protected]

051.63.66 ext. 199

Emanuela Palmerini, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue

Other

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 outcomes

  1. event free survival

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emanuela Palmerini, MD

CONTACT

[email protected]

051.63.66 ext. 199

Marco Gambarotti, MD

CONTACT

[email protected]

051.63.66 ext. 652

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: GRACefUl

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
May 3, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.