Clinical trial NCT04300257: Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care
Official title: Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Keywords: Sarcoma, Epithelioid
Sarcoma, Soft Tissue
Sarcoma, Spindle Cell
Sarcoma, Bone
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
Collaborators: name: Swiss Sarcoma Network
First posted: 2020-03-09
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from bone or soft tissue tumors.

Brief summary: 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.

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

Primary outcomes:
measure: Diagnosis,
timeFrame: 5 years
measure: Local recurrence,
timeFrame: 5 years
measure: distant metastasis,
timeFrame: 5 years
measure: biopsy taken by operating surgeon-radiologist-team,
timeFrame: 5 years
measure: pathology centrally reviewed,
timeFrame: 5 years
measure: Surgery (yes/no),
timeFrame: 5 years
measure: Surgical margin status,
timeFrame: 5 years
measure: surgery performed by dedicated surgeon,
timeFrame: 5 years
measure: Radiation Therapy (yes/no),
timeFrame: 5 years
measure: Chemotherapy (yes/no),
timeFrame: 5 years
measure: decision of board carried out,
timeFrame: 5 years
measure: Status at last contact,
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
state: Graubünden
city: Bellinzona
country: Switzerland
facility: Ente Ospedaliero Cantonale
state: Tessin
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zuerich
city: Winterthur
country: Switzerland
facility: SwissSarcomaNetwork
state: Zürich
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: Pathologie Institut Enge
city: Zürich
country: Switzerland
facility: Klinik Hirslanden
city: Zürich
country: Switzerland
facility: Stadtspital Zürich Triemli
Study officials:
affiliation: SwissSarcomaNetwork
name: Bruno Fuchs, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Crit Rev Oncol Hematol. 2017 Feb;110:94-105. doi: 10.1016/j.critrevonc.2016.12.002. Epub 2016 Dec 8.
citation: 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.