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NCT05741944Active, not recruiting

The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients

Source: ClinicalTrials.gov · Last updated 9 Sept 2025

Brief summary (registry, in English)

The goal of this clinical trial is to assess the (cost-)effectiveness of a personalised risk assessment tool (PERSARC) to increase patients' knowledge about risks and benefits of treatment options and to reduce decisional conflict in comparison with usual care in high-grade extremity Soft-Tissue Sarcoma-patients. High-grade (2-3) extremity Soft-Tissue Sarcoma patients (\>= 18 years) will either receive standard care (control group) or care with the use of PERSARC; i.e. PERSARC will be used in multidisciplinary tumour boards to guide treatment advice and in consultation in which the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and discusses the benefits and harms of all relevant treatment options (intervention group)

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
120 (estimated)
First submitted
31 Jan 2023
Start date
24 Aug 2021
Primary completion date
29 Aug 2024
Lead sponsor
Leiden University Medical Center
Diseases
Sarcoma
NCT number
NCT05741944

What you commit to

  • Study type: Interventional
  • Planned participants: 120
  • From 24 Aug 2021 to the primary completion date, 29 Aug 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient that needs to be treated with chemotherapy or isolated limb perfusion
  • Patients were surgery is not indicated
  • Sarcoma subtypes not included in the PERSARC risk assessment tool
    • In summary: patients with sarcoma subtypes and/or patients that need to be treated with other treatment modalities than those included in the PERSARC risk assessment tool are excluded.

Other

  • Patient that are treated without curative intent

Who the study is looking for

  • Patients \>= 18 years
  • Histologically diagnosed with grade 2-3 STS in their extremities.
  • Who do not have a treatment plan yet
  • Dutch fluency and literacy
  • Mentally competent
  • Signed informed consent
  • Patient owns a phone with internet access (WiFi)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Netherlands Cancer Institue
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
UMC Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsUnknown status
Leiden University Medical Center
Coordinator of this site? Confirm its status
LeidenNetherlandsUnknown status
Maastricht UMC
Coordinator of this site? Confirm its status
MaastrichtNetherlandsUnknown status
Radboud UMC
Coordinator of this site? Confirm its status
NijmegenNetherlandsUnknown status
Erasmus MC
Coordinator of this site? Confirm its status
RotterdamNetherlandsUnknown status
UMC Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.