Registration Study Sarcoma
Overview
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.
Full Title of Study: “Registration Study on Bone and Soft Tissue Sarcoma – An Observational Cohort Study -“
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: April 2, 2029
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
- Other: Surgery
- all interventions are allowed
Clinical Trial Outcome Measures
Primary Measures
- to provide more accurate data on treatment and clinical outcome
- Time Frame: up to 10 years
- more accurate data on treatment and clinical outcome
Secondary Measures
- Patient reported outcome measures
- Time Frame: during the study up to 5 years
- PROMS
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Radboud University Medical Center
- Collaborator
- Radiotherapiegroep
- Provider of Information About this Clinical Study
- Sponsor
- Overall Contact(s)
- Pètra Braam, MD/PhD, +31243614515, p.braam@radboudumc.nl
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