SarcomaNCT04300257
Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care
An observational study of Sarcoma, run by Kantonsspital Winterthur KSW at 8 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- How many people
- 600 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 19 Oct 2019to 31 Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from bone or soft tissue tumors.
Who may be able to join
- 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
Who cannot join
- Documented objection of subsequent use of personal health data
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Switzerland8 sites, 8 recruiting
- Recruiting
Ente Ospedaliero Cantonale
Bellinzona, Canton Ticino, 6500
Silke Gillessen Sommer, Prof. Dr. med., +41 91 811 94 10
- Recruiting
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Christian Michelitsch, Dr. med., +41 81 256 62 05
- Recruiting
Luzerner Kantonsspital
Lucerne, 6000
Gabriela Studer, Prof. Dr. med., +41 41 205 58 01
- Recruiting
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
Stefan Breitenstein, Prof. Dr. med., +41 52 266 2121
Bruno Fuchs, MD PhD, +41 52 266 2121 ext. 2553, bruno.fuchs@ksw.ch
- Recruiting
SwissSarcomaNetwork
Winterthur, Canton of Zurich, 8400
Larissa Slater, +41 52 266 24 88, larissa.slater@ksw.ch
- Recruiting
Pathologie Institut Enge
Zurich, 8005
Beata Bode, Prof. Dr. med., +41 44 287 38 38
- Recruiting
Klinik Hirslanden
Zurich, 8032
Paul Magnus Schneider, Prof. Dr., +41 44 387 31 66, sekretariat.professor-schneider@hin.ch
Annelies Schnider, Dr. med.
- Recruiting
Stadtspital Zürich Triemli
Zurich, 8063
Markus Weber, Prof. Dr. med. Dr. h.c., +41 44 416 43 01
About this study
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.
Read the 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.
- Conditions
- Sarcoma
- Keywords
- Sarcoma, Epithelioid, Sarcoma, Soft Tissue, Sarcoma, Spindle Cell, Sarcoma, Bone
- Medical subject headings
- Sarcoma, Osteosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis,
Data collected in the registry will be evaluated and analyzed to determine criteria to improve treatment strategies
Measured: 5 years
Local recurrence,
s.o.
Measured: 5 years
distant metastasis,
s.o.
Measured: 5 years
biopsy taken by operating surgeon-radiologist-team,
s.o.
Measured: 5 years
pathology centrally reviewed,
s.o.
Measured: 5 years
Surgery (yes/no),
s.o.
Measured: 5 years
Surgical margin status,
s.o.
Measured: 5 years
surgery performed by dedicated surgeon,
s.o.
Measured: 5 years
Radiation Therapy (yes/no),
s.o.
Measured: 5 years
Chemotherapy (yes/no),
s.o.
Measured: 5 years
decision of board carried out,
s.o.
Measured: 5 years
Status at last contact,
s.o.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start19 Oct 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Sarcoma Network
- Responsible party
- Sponsor
- Investigators
- Bruno Fuchs, Prof, Principal investigator, SwissSarcomaNetwork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300257
- Sponsor's protocol ID
- 2019-01107
- Other IDs
- 2019
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. Crit Rev Oncol Hematol. 2017 Feb;110:94-105. doi: 10.1016/j.critrevonc.2016.12.002. Epub 2016 Dec 8.
PubMed 28109409Abarca 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.
PubMed 29633281
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care
- ClinicalTrials.gov ID
- NCT04300257
- Acronym / sponsor ID
- 2019-01107
- Conditions
- Sarcoma
- Keywords
- Sarcoma, Epithelioid, Sarcoma, Soft Tissue, Sarcoma, Spindle Cell, Sarcoma, Bone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- Swiss Sarcoma Network
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from bone or soft tissue tumors.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Documented objection of subsequent use of personal health data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis,
Time frame: 5 years
Data collected in the registry will be evaluated and analyzed to determine criteria to improve treatment strategies
Local recurrence,
Time frame: 5 years
s.o.
distant metastasis,
Time frame: 5 years
s.o.
biopsy taken by operating surgeon-radiologist-team,
Time frame: 5 years
s.o.
pathology centrally reviewed,
Time frame: 5 years
s.o.
Surgery (yes/no),
Time frame: 5 years
s.o.
Surgical margin status,
Time frame: 5 years
s.o.
surgery performed by dedicated surgeon,
Time frame: 5 years
s.o.
Radiation Therapy (yes/no),
Time frame: 5 years
s.o.
Chemotherapy (yes/no),
Time frame: 5 years
s.o.
decision of board carried out,
Time frame: 5 years
s.o.
Status at last contact,
Time frame: 5 years
s.o.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Results publication: PubMed 28109409Andritsch 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.
- Results publication: PubMed 29633281Abarca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno Fuchs, Prof principal investigator
SwissSarcomaNetwork
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Kantonsspital Winterthur KSW at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Fuchs, Prof. (+41 52 266 25 33, bruno.fuchs@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis, (time frame: 5 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300257, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.