Registration Study Sarcoma

May 16, 2022 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Arnhem, Netherlands
        • Recruiting
        • Radiotherapiegroep
        • Contact:
          • Marjan van Hezewijk, MD/PhD
      • Nijmegen, Netherlands
        • Recruiting
        • Radboudumc
        • Contact:
          • Pètra Braam, MD/PhD
        • Contact:
          • Ingrid Desar, MD/PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with bone or soft tissue sarcoma who are recently diagnosed, currently under treatment or have been treated will be asked to participate in this cohort study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: up to 10 years
PFS
up to 10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Radiotherapiegroep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2019

Primary Completion (Anticipated)

April 2, 2029

Study Completion (Anticipated)

April 2, 2029

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

May 12, 2022

First Posted (Actual)

May 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL69559.091.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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