NCT05051059 Assessment of the Functional Outcome and Quality of Life in Sarcoma Patients
| NCT ID | NCT05051059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-10-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary bone and soft tissue sarcomas are an exceptionally rare form of cancer, collectively accounting for only 1% of all malignancies diagnosed. Sarcomas often occur in the patients' extremities and treatment typically involves limb salvage surgery with bone and/or muscle resection. These surgeries often leave the patients with disfigurements, psychological trauma, and functional disabilities. Perhaps, the most difficult and life-altering decision that patients (and their parents) with primary bone sarcomas about the knee joint have to make, involves choosing the type of surgical procedure that will provide them with the outcome that meets their functional as well as aesthetic expectations. In literature, the quality of life for patients with osteosarcoma around the knee joint after three different surgical procedures, that is, amputation, endoprosthetic reconstruction and rotationplasty was evaluated. There was found that patients treated with rotationplasty showed significantly higher functional scores compared to the two other groups of patients. Also, researchers investigated the long-term quality of life after bone sarcoma surgery around the knee joint and found that, despite the functional disability, survivors were busy with work, study, relationships, and sometimes they have founded a family. Most published reports in the literature on assessment of gait in the lower-extremity sarcoma survivors were focused on bone sarcoma patients after wide resection and endoprosthetic reconstruction. To the knowledge of the investigator, there has been no published studies on gait analysis after resection of soft tissue sarcomas (STS) of the lower extremity. The rare and heterogeneous aspects of STS and the paucity of knowledge of movement strategies in these patients hinder the development of effective rehabilitation protocols for recovering movement after resection of STS in the lower limb.
Eligibility Criteria
Inclusion Criteria: * Patients who underwent limb salvage surgery for bone or soft tissue sarcoma of the lower extremity at UZ Leuven * 18 to 95 years old * Patients should be at least one year post surgery * Informed consent has obtained Exclusion Criteria: * Patients who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system * Skeletally immature individuals * No informed consent has obtained
Contact & Investigator
Hazem Wafa
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT05051059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05051059 currently recruiting?
Yes, NCT05051059 is actively recruiting participants. Contact the research team at hazem.wafa@uzleuven.be for enrollment information.
Where is the NCT05051059 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05051059 clinical trial?
NCT05051059 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Hazem Wafa at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 60 participants.