Registration Study Sarcoma

Recruiting

• Conditions: Sarcoma

• Registration Number: NCT05373810
• Lead Sponsor: Radboud University Medical Center

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

Study Timeline

• Study Start: 2019-07-29
• Study First Submitted: 2021-01-22
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-13
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-23
• Primary Completion: 2029-04-02
• Study Completion: 2029-04-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival	up to 10 years	PFS

Secondary Outcome Measures

Name	Time	Method
grade 3/4 serious adverse events	up to 5 years	AE
Overall survival	up to 10 years	OS
Disease free survival	up to 10 years	DFS
Health related quality of life	up to 5 years	measured by EORTC QOL questionnaires

Trial Locations

Locations (2)

Radiotherapiegroep; 🇳🇱 Arnhem, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands