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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04300257
Other study ID # 2019-01107
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 19, 2019
Est. completion date December 31, 2029

Study information

Verified date March 2024
Source Kantonsspital Winterthur KSW
Contact Bruno Fuchs, Prof.
Phone +41 52 266 25 33
Email bruno.fuchs@ksw.ch
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Ente Ospedaliero Cantonale Bellinzona Tessin
Switzerland Kantonsspital Graubünden Chur Graubünden
Switzerland Luzerner Kantonsspital Lucerne
Switzerland Kantonsspital Winterthur Winterthur Zuerich
Switzerland SwissSarcomaNetwork Winterthur Zürich
Switzerland Klinik Hirslanden Zürich
Switzerland Pathologie Institut Enge Zürich
Switzerland Stadtspital Zürich Triemli Zürich

Sponsors (2)

Lead Sponsor Collaborator
Kantonsspital Winterthur KSW Swiss Sarcoma Network

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis, Data collected in the registry will be evaluated and analyzed to determine criteria to improve treatment strategies 5 years
Primary Local recurrence, s.o. 5 years
Primary distant metastasis, s.o. 5 years
Primary biopsy taken by operating surgeon-radiologist-team, s.o. 5 years
Primary pathology centrally reviewed, s.o. 5 years
Primary Surgery (yes/no), s.o. 5 years
Primary Surgical margin status, s.o. 5 years
Primary surgery performed by dedicated surgeon, s.o. 5 years
Primary Radiation Therapy (yes/no), s.o. 5 years
Primary Chemotherapy (yes/no), s.o. 5 years
Primary decision of board carried out, s.o. 5 years
Primary Status at last contact, s.o. 5 years
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