Clinical Research Directory

Exercise Rehabilitation to Improve Long-term Outcomes in Sarcoma Survivors.

People who have had a sarcoma removed from the leg often live with weak muscles, stiff joints, and trouble walking. These problems can last for years. Formal medical follow-up usually ends about five years after treatment. Few studies have tested exercise at this stage. This study tested an 8-week supervised exercise program. Participants were adults aged 18 to 67 who were at least 5 years past limb-sparing (wide resection) surgery for a leg sarcoma. They attended a clinic in Perth, Western Australia, twice a week for one hour. The program built leg strength, joint movement, balance, walking, and fitness. It progressed through three phases and was matched to each person's surgery and ability. All participants received the same program type. There was no comparison group. Each person was tested twice before starting to confirm stable function. Testing was repeated at the end of the 8 weeks. It was repeated again 8 weeks later, after a period with no supervised exercise. The main outcome was high-level mobility, measured by the High-level Mobility Assessment Tool (HiMAT). This tool scores walking, running, hopping, and stair climbing. Other outcomes were six-minute walk distance, leg strength, joint range of motion, and self-reported physical function and quality of life (TESS and SF-36 questionnaires). The study aimed to learn two things. First, whether exercise improves strength and mobility years after sarcoma surgery. Second, whether those gains last after supervision stops.

Characterization of the Methylation Profile of Stored Human Samples

The project, funded by the PNRR under Mission 4 "Education and Research," aims to strengthen the network of Italian biobanks by improving data management in accordance with the FAIR principles (Findable, Accessible, Interoperable, Reusable). The University of Trento has issued a call for proposals to support Italian biobanks in characterizing samples and expanding associated datasets using advanced technologies. The Biological Resource Center at the Rizzoli Orthopedic Institute in Bologna participated in this call for proposals, requesting funding to analyze the DNA methylation profiles of three patient cohorts: those with inflammatory/degenerative diseases, sarcomas, and rare genetic musculoskeletal disorders. This study will contribute to understanding the biological significance of methylation and exploring its diagnostic and therapeutic potential. The initiative aims to generate data useful for personalized medicine and improve the management of the diseases involved.

Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas

This is an open-label, non-randomized, multicenter Phase 1/2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.

The Sarcoma Biology and Outcome Project

SarcBOP - An interdisciplinary and translational registry SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical, pathologic, and radiologic information, multi-layered molecular data, and patient-reported outcomes, combined with a dedicated biobank for tissue samples and liquid biopsies. As the study integrates seamlessly with the clinical activities of the Heidelberg Sarcoma Center, the Molecular Diagnostics Program of NCT Heidelberg, including the NCT/DKTK MASTER Program, and with the NCT Trial Center, including the PMO Clinical Trials Program, SarcBOP will generate a comprehensive and continuously growing resource for clinicians, researchers, and, finally, patients.