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Recruiting NCT04300257

Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care

Observational Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sarcoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The primary significance of this project is to perform a detailed analysis to assess the diagnostics, treatment and follow-up care, to develop a prediction model for future patient selection regarding various diagnostic and treatment procedures.

Detailed description

Within the framework of interdisciplinary cooperation for a sarcoma problem, predictive and prognostic criteria will be developed that improve the treatment and particularly outcome.

The outcome variables include patient characteristics, tumor types and characteristics, histology, management and treatment strategies as well as recurrence rate and overall survival.

Primary outcome measures

  • Diagnosis, [Time frame: 5 years]
  • Local recurrence, [Time frame: 5 years]
  • distant metastasis, [Time frame: 5 years]
  • biopsy taken by operating surgeon-radiologist-team, [Time frame: 5 years]
  • pathology centrally reviewed, [Time frame: 5 years]
  • Surgery (yes/no), [Time frame: 5 years]
  • Surgical margin status, [Time frame: 5 years]
  • surgery performed by dedicated surgeon, [Time frame: 5 years]
  • Radiation Therapy (yes/no), [Time frame: 5 years]
  • Chemotherapy (yes/no), [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Malignant and intermediate and selected benign bone or soft tissue tumors, acc. to the WHO coding list of the SSN
  • Female and male subjects of all ages

Exclusion criteria

  • Documented objection of subsequent use of personal health data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 8 centers
  • Kantonsspital Winterthur — Winterthur
  • SwissSarcomaNetwork — Winterthur
  • Ente Ospedaliero Cantonale — Bellinzona
  • Kantonsspital Graubünden — Chur
  • Luzerner Kantonsspital — Lucerne
  • Pathologie Institut Enge — Zurich
  • Klinik Hirslanden — Zurich
  • Stadtspital Zürich Triemli — Zurich

Publications

  • Andritsch E, Beishon M, Bielack S, Bonvalot S, Casali P, Crul M, Delgado Bolton R, Donati DM, Douis H, Haas R, Hogendoorn P, Kozhaeva O, Lavender V, Lovey J, Negrouk A, Pereira P, Roca P, de Lempdes GR, Saarto T, van Berck B, Vassal G, Wartenberg M, Yared W, Costa A, Naredi P. ECCO Essential Requirements for Quality Cancer Care: Soft Tissue Sarcoma in Adults and Bone Sarcoma. A critical review. Cr PMID 28109409
  • Abarca T, Gao Y, Monga V, Tanas MR, Milhem MM, Miller BJ. Improved survival for extremity soft tissue sarcoma treated in high-volume facilities. J Surg Oncol. 2018 Jun;117(7):1479-1486. doi: 10.1002/jso.25052. Epub 2018 Apr 6. PMID 29633281

Identifiers

NCT: NCT04300257 · 2019-01107

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗