Soft Tissue Sarcoma Registry 2.0-NIS

Soft Tissue Sarcoma Registry 2.0-NIS - SoTiSaR 2.0-NIS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00039678

Enrollment

3000

Registered

2026-04-21

Start date

2024-12-11

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C49

Interventions

Group 1: 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 collectio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: no STS Tumors

Design outcomes

Primary

Measure	Time frame
• 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 • 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 use - 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 • If additional drugs are approved for RMS/NRSTS in the near future, they will also be documented in SoTiSaR 2.0-NIS • 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	—

Measure

Time frame

• 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 • 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 use - 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 • If additional drugs are approved for RMS/NRSTS in the near future, they will also be documented in SoTiSaR 2.0-NIS • 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

—

Secondary

Measure	Time frame
• Provide a basis for innovative clinical phase-I/-II/-III trials being prepared in cooperation with other national and international groups. Their feasibility is depending on the existence of a registry for standardised treated patients with all types and risk groups of soft tissue sarcoma (STS). • Provide a basis for innovative clinical phase-II and -III trials and for allocation of patients into phase I-II trials on targeted therapies • Provide a clinical data basis for an independent sarcoma tumour and tissue repository • Identify sarcoma specific surrogate endpoints • Facilitate the conduct of other clinical and laboratory-based sarcoma research • Serve as an information resource for sarcoma researchers, clinicians and patients • Conduct long-term follow-up to assess late morbidities and quality of life (in cooperation with the late effects groups) and to identify late effects of disease and treatment • Implement high-quality information systems by optimising the linkage between data from the registry, data from the clinical trials conducted by the CWS Study Group and data from biological studies e.g. INFORM.	—

Measure

Time frame

• Provide a basis for innovative clinical phase-I/-II/-III trials being prepared in cooperation with other national and international groups. Their feasibility is depending on the existence of a registry for standardised treated patients with all types and risk groups of soft tissue sarcoma (STS). • Provide a basis for innovative clinical phase-II and -III trials and for allocation of patients into phase I-II trials on targeted therapies • Provide a clinical data basis for an independent sarcoma tumour and tissue repository • Identify sarcoma specific surrogate endpoints • Facilitate the conduct of other clinical and laboratory-based sarcoma research • Serve as an information resource for sarcoma researchers, clinicians and patients • Conduct long-term follow-up to assess late morbidities and quality of life (in cooperation with the late effects groups) and to identify late effects of disease and treatment • Implement high-quality information systems by optimising the linkage between data from the registry, data from the clinical trials conducted by the CWS Study Group and data from biological studies e.g. INFORM.

—

Countries

Austria, Finland, Germany, Poland, Sweden, Switzerland

Contacts

Public ContactMonika Sparber-Sauer

Klinikum Stuttgart Olgahospital

M.Sparber-Sauer@klinikum-stuttgart.de+49 (0)711-278-73870

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026