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)
    • P├Ętra Braam, MD/PhD, +31243614515, p.braam@radboudumc.nl

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.