SoTiSaR 2.0-NIS

Prospectively register all newly diagnosed patients (children, adolescents, and young adults) with rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma and tumours within a non-interventional study (NIS) with the following aims:

1) Data collection
  - Collect data on patients obtained within routinely workup and standard treatment given in the participating centres outside clinical trials. Off-label use will not be included into this registry/NIS.
  - Collect information about incidence of different types of soft tissue tumours as a rare disease
  - Assess the quality of treatment by the means of data collection and data check provided by the registry and the CWS reference centres.
  - Prospectively collect information on epidemiologic, diagnostic, molecular, clinical and treatment data of patients with STS and other soft tissue tumours to determine whether a relationship exists between outcomes and specific characteristics
  - Collect survival data including long-term follow-up, quality of life

2) Observation of the use of approved or licensed drugs INSIDE the approved indications, population, and/or posology (NO off-label use):
- RMS treated with standard regimens (only if not included into the FaR-RMS study). No off-label use1
- NTRK positive NRSTS treated with NTRK inhibitors
- ALK positive NRSTS (inflammatory myofibroblastic tumours) treated with ALK inhibitors
- NRSTS treated with standard systemic treatment. No off-label use1

3) If additional drugs are approved for RMS/NRSTS in the near future, they will also be documented in SoTiSaR 2.0-NIS
4) Create a database for the reassessment of the present therapy stratification system and find new risk factors by the linkage of biological information to long-term outcome

• Pathologically and molecular proven diagnosis of a soft tissue tumour or sarcoma (centrally reviewed), all ages, available for long term follow up, written informed consent for data collection.