Registration Study Sarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgery.
- Who it may be relevant to
- Registry conditions: Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -
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.
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
Primary outcome measures
- Progression free survival [Time frame: up to 10 years]
Secondary outcome measures (4)
- Health related quality of life [Time frame: up to 5 years]
- grade 3/4 serious adverse events [Time frame: up to 5 years]
- Disease free survival [Time frame: up to 10 years]
- Overall survival [Time frame: up to 10 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Radiotherapiegroep — Arnhem
- Radboudumc — Nijmegen
Identifiers
NCT: NCT05373810 · NL69559.091.19