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

May 16, 2023 updated by: Istituto Ortopedico Rizzoli
Experimental study with biological material : case series review of clinical and histological data

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • Recruiting
        • IRCCS Istituto Ortopedico Rizzoli
        • Principal Investigator:
          • Emanuela Palmerini, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

male and femalke patient without limit of age with a diagnosis of undifferentiated round cell sarcomas treated from 01 January 1983 and all new cases referring to each participant site.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
event free survival
Time Frame: baseline
Correlate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2019

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 27, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRACefUl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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