SarcomaNCT05373810
Registration Study Sarcoma
An observational study of Sarcoma, run by Radboud University Medical Center at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Surgery
- How many people
- 1,000 participants
- Where
- 2 sitesNetherlands
- Study dates
- 29 Jul 2019to 2 Apr 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours
Who cannot join
- Altered mental status that would prohibit the understanding of and giving of informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Radiotherapiegroep
Arnhem
Marjan van Hezewijk, MD/PhD
- Recruiting
Radboudumc
Nijmegen
Pètra Braam, MD/PhD
Ingrid Desar, MD/PhD
About this study
Official title: 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.
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
- Conditions
- Sarcoma
- Being tested
- Surgery
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Also called Radiation, Systemic treatment
all interventions are allowed
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
PFS
Measured: up to 10 years
Secondary outcomes (4)
Health related quality of life
measured by EORTC QOL questionnaires
Measured: up to 5 years
grade 3/4 serious adverse events
AE
Measured: up to 5 years
Disease free survival
DFS
Measured: up to 10 years
Overall survival
OS
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start29 Jul 2019
- Primary completion2 Apr 2029 (estimated)
- Study completion2 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radiotherapiegroep
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373810
- Sponsor's protocol ID
- NL69559.091.19
- Status last verified
- May 2022
- First submitted
- 22 Jan 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration Study on Bone and Soft Tissue Sarcoma - An Observational Cohort Study -
- ClinicalTrials.gov ID
- NCT05373810
- Acronym / sponsor ID
- NL69559.091.19
- Conditions
- Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Radiotherapiegroep
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 2 Apr 2029 (estimated)
- Study completion
- 2 Apr 2029 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Histologically proven bone or soft tissue sarcoma, excluding Gastrointestinal Stromal Tumours
Key exclusion criteria (1 listed)
- Altered mental status that would prohibit the understanding of and giving of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryAlso: Radiation, Systemic treatmentall interventions are allowed | Other | – |
Primary outcome
Progression free survival
Time frame: up to 10 years
PFS
4 secondary outcomes
Health related quality of life
Time frame: up to 5 years
grade 3/4 serious adverse events
Time frame: up to 5 years
Disease free survival
Time frame: up to 10 years
Overall survival
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
Related trials for Sarcoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pètra Braam, MD/PhD (+31243614515, p.braam@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 29 Oct 2026.