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RecruitingNCT05373810Updated May 23, 2022

Registration Study Sarcoma

An observational study in Sarcoma, sponsored by Radboud University Medical Center. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by Radboud University Medical Center · Observational

From the registry’s dates

  • Started Jul 2019; still recruiting 7 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Sarcoma

Browse trials for

03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours

Exclusion criteria

Exclusion Criteria:

  • Altered mental status that would prohibit the understanding of and giving of informed consent
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Interventions

  • OtherSurgery

    all interventions are allowed

    Also known as: Radiation, Systemic treatment

06

What researchers measure

Primary outcomes

  1. Progression free survival

    PFS

    Time frame: up to 10 years

Secondary outcomes

  1. Health related quality of life

    measured by EORTC QOL questionnaires

    Time frame: up to 5 years

  2. grade 3/4 serious adverse events

    AE

    Time frame: up to 5 years

  3. Disease free survival

    DFS

    Time frame: up to 10 years

  4. Overall survival

    OS

    Time frame: up to 10 years

07

Study locations

2 of 2 sites recruiting
  • Radiotherapiegroep
    Arnhem, Netherlands
    • Marjan van Hezewijk, MD/PhD · Contact
    Recruiting
  • Radboudumc
    Nijmegen, Netherlands
    • Pètra Braam, MD/PhD · Contact
    • Ingrid Desar, MD/PhD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05373810
Lead sponsor
Radboud University Medical Center
Collaborators
Radiotherapiegroep
Responsible party
Sponsor
First posted
May 13, 2022
Start date
Jul 29, 2019
Primary completion
Apr 2, 2029 (estimated)
Completion
Apr 2, 2029 (estimated)
Last update
May 23, 2022

Study contacts

Pètra Braam, MD/PhD
Contact
p.braam@radboudumc.nl
+31243614515
Ingrid Desar, MD/PhD
Contact
ingrid.desar@radboudumc.nl
+31243610353

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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