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Registration Study Sarcoma

Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05373810
Enrollment
1000
Registered
2022-05-13
Start date
2019-07-29
Completion date
2029-04-02
Last updated
2022-05-23

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

Conditions

Sarcoma

Brief summary

The prospective and retrospective data collection on bone and soft tissue sarcoma is an observational cohort study aimed to collect clinical data and patient reported outcomes of all patients who have been diagnosed with bone or soft tissue sarcoma in the Netherlands. All patients diagnosed with bone or soft tissue sarcoma who are treated, planned for treatment or currently being treated, will be asked to participate in this project.

Detailed description

The main objectives of this project are: * To improve the knowledge and therefore the treatment care, in patients with bone or soft tissue sarcoma in the Netherlands * To start an observational cohort study of bone and soft tissue sarcoma patients from their primary diagnosis until death * To prospectively and retrospectively collect data on medical history, co-morbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, functional outcome, cosmetic outcome, hospital stays and interventions. * To collect data on health related quality of life and work ability, to collect data on patient reported outcomes measures. * To create a continuous basis for a large variety of research purposes including: * Prognostic and predictive research * Health care policies and cost-effectiveness studies

Interventions

OTHERSurgery

all interventions are allowed

Sponsors

Radiotherapiegroep
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours

Exclusion criteria

* Altered mental status that would prohibit the understanding of and giving of informed consent

Design outcomes

Primary

MeasureTime frameDescription
Progression free survivalup to 10 yearsPFS

Secondary

MeasureTime frameDescription
Health related quality of lifeup to 5 yearsmeasured by EORTC QOL questionnaires
grade 3/4 serious adverse eventsup to 5 yearsAE
Disease free survivalup to 10 yearsDFS
Overall survivalup to 10 yearsOS

Countries

Netherlands

Contacts

Primary ContactPètra Braam, MD/PhD
p.braam@radboudumc.nl+31243614515
Backup ContactIngrid Desar, MD/PhD
ingrid.desar@radboudumc.nl+31243610353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026