Undifferentiated Round Cell SarcomaGRACefUlNCT05357768
Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project
An observational study of Undifferentiated Round Cell Sarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Experimental study with biological material : case series review of clinical and histological data Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Undifferentiated Round Cell Sarcoma
- What is being tested?
- data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jun 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Diagnosis different from undifferentiated round cell sarcomas
- Patient with no clinical or outcome information available
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCs Istituto Ortopedico Rizzoli
Bologna, BO, 40136
Emanuela Palmerini, MD, 051.63.66 ext. 199, emanuela.palmerini@ior.it
Emanuela Palmerini, MD
About this study
Experimental study with biological material : case series review of clinical and histological data
Read the 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.
- Conditions
- Undifferentiated Round Cell Sarcoma
- Being tested
- data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue | |
| 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. Receives: Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
event free survival
Correlate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start11 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Round Cell SarcomaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357768
- Sponsor's protocol ID
- GRACefUl
- Acronym
- GRACefUl
- Status last verified
- May 2025
- First submitted
- 27 Apr 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global collaboRAtion on CIC-DUX4, BCOR-CCN3, High-grade Undifferentiated Round Cell Sarcoma (URCS) Project
- ClinicalTrials.gov ID
- NCT05357768
- Acronym / sponsor ID
- GRACefUl / GRACefUl
- Conditions
- Undifferentiated Round Cell Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective cohort | – | Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissuePatients 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 | – | Other: data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissueprospective patients with undifferentiated round cell sarcomas will be included in the study. For prospective study, it is expect to include 60 patients. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Diagnosis different from undifferentiated round cell sarcomas
- Patient with no clinical or outcome information available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection and analysis on Formalin-fixed paraffin embedded tissue and/or frozen tumoral tissueFormalin-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. | Other | prospective cohort, retrospective cohort |
Primary outcome
event free survival
Time frame: baseline
Correlate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undifferentiated Round Cell Sarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuela Palmerini, MD (051.63.66 ext. 199, emanuela.palmerini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event free survival (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.