NCT06873685 Soft Tissue Sarcoma: Motor Performance, Robotic Rehabilitation, Nutrition, and Quality of Life
| NCT ID | NCT06873685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico |
| Condition | Sarcoma, Soft Tissue |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2025-12-31 |
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 120 participants in total. It began in 2025-03-13 with a primary completion date of 2025-12-31.
⚠ 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
Soft tissue sarcomas are a group of rare and heterogeneous tumors. Surgery is the mainstay of treatment and microscopic negative margins need to be achieved to improve disease local control. We designed this prospective study to evaluate the main features of motor impairment and the impact of tailored robotic rehabilitation techniques in patients treated for localized soft tissue sarcoma (surgery alone, or surgery + radiation or radiochemotherapy). Specific patients' motor strategies will be quantitatively measured through a biomechanical assessment, including the analysis of joint kinematics, and muscle activity timing patterns. Considering the influence of motor impairment after demolitive surgery, a major interest of this study will be focused on nutrition and Quality of life which will be prospectively evaluated by specific questionnaires at different time points.
Eligibility Criteria
Inclusion Criteria: 1. patient with primary and localized STS who is a candidate for limb-sparing surgery or retroperitoneal multivisceral resection (including partial or complete resection of the iliopsoas muscle with functional loss and potential femoral nerve involvement) with curative intent; 2. age 18 years or older. Exclusion Criteria: 1. recurrent tumors; 2. metastatic disease; 3. candidate for palliative and non-radical surgery; 4. refusal to sign informed consent; 5. Pregnant or breastfeeding women at the time of screening.
Contact & Investigator
Bruno Vincenzi, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Campus Bio-Medico
Frequently Asked Questions
Who can join the NCT06873685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoma, Soft Tissue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06873685 currently recruiting?
Yes, NCT06873685 is actively recruiting participants. Contact the research team at b.vincenzi@policlinicocampus.it for enrollment information.
Where is the NCT06873685 trial being conducted?
This trial is being conducted at Rome, Italy, Roma, Italy, Naples, Italy.
Who is sponsoring the NCT06873685 clinical trial?
NCT06873685 is sponsored by Fondazione Policlinico Universitario Campus Bio-Medico. The principal investigator is Bruno Vincenzi, MD, PhD at Fondazione Policlinico Universitario Campus Bio-Medico. The trial plans to enroll 120 participants.