Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcoma
- Sponsor
- Radboud University Medical Center
- Enrollment
- 1000
- Locations
- 2
- Primary Endpoint
- Progression free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Progression free survival
Time Frame: up to 10 years
PFS
Secondary Outcomes
- grade 3/4 serious adverse events(up to 5 years)
- Overall survival(up to 10 years)
- Disease free survival(up to 10 years)
- Health related quality of life(up to 5 years)