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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-11

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Undifferentiated Round Cell Sarcoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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

Intervention Type 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.

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

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCs Istituto Ortopedico Rizzoli

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Emanuela Palmerini, MD

Role: CONTACT

051.63.66 ext. 199

Marco Gambarotti, MD

Role: CONTACT

051.63.66 ext. 652

Facility Contacts

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Emanuela Palmerini, MD

Role: primary

051.63.66 ext. 199

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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GRACefUl

Identifier Type: -

Identifier Source: org_study_id

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