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Experimental study with biological material : case series review of clinical and histological data
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| event free survival | Correlate clinical and pathological variables with event-free survival and overall-survival in undifferentiated round cell sarcomas. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuela Palmerini, MD | Contact | 051.63.66 | 199 | emanuela.palmerini@ior.it |
| Marco Gambarotti, MD | Contact | 051.63.66 | 652 | marco.gambarotti@ior.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCs Istituto Ortopedico Rizzoli | Recruiting | Bologna | BO | 40136 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2023 | Mar 21, 2023 |
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| Prot_001.pdf |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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