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

NCT05741944 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-09

No results posted yet for this study

Summary

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)

Conditions

  • Soft-tissue Sarcoma
  • Predictive Cancer Model

Interventions

OTHER

Care with the use of PERSARC

PERSARC is a personalized risk assessment tool which provides patients and STS professionals insight into the personalized risks and benefits of each treatment option based on patient's age, tumor size, tumor depth and histology. 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

OTHER

standard care

All patients in control condition receive usual care.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Leti van Bodegom-Vos, PhD · LUMC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-24
Primary Completion
2024-08-29
Completion
2025-08-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05741944 on ClinicalTrials.gov