Registration Study Sarcoma

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373810
• Other study ID #: NL69559.091.19
• Status: Recruiting
• Start date: July 29, 2019
• Est. completion date: April 2, 2029

Study information

• Verified date: May 2022
• Source: Radboud University Medical Center
• Contact: Pètra Braam, MD/PhD
• Phone: +31243614515
• Email: p.braam[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2, 2029
• Est. primary completion date: April 2, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma

Intervention

Other:
• Surgery
all interventions are allowed

Locations

Country	Name	City	State
Netherlands	Radiotherapiegroep	Arnhem
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Radiotherapiegroep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	PFS	up to 10 years
Secondary	Health related quality of life	measured by EORTC QOL questionnaires	up to 5 years
Secondary	grade 3/4 serious adverse events	AE	up to 5 years
Secondary	Disease free survival	DFS	up to 10 years
Secondary	Overall survival	OS	up to 10 years