Study of Blood and Tissue Collection for Immune Analysis During Pre-Surgery Therapy in Adults with High-Risk Soft Tissue Sarcoma

What this Trial Is About

Researchers are studying adults with high-risk soft tissue sarcoma who are eligible for neoadjuvant multimodal therapy, which may include radiotherapy, chemotherapy, hyperthermia, and surgery. The study aims to explore immunological aspects by collecting blood and tissue samples before and after treatment, along with advanced imaging, to better understand the immune response and tumor characteristics during therapy. This research also includes translational studies examining tumor cell behavior and immune cell interactions. Participants receive standard neoadjuvant therapy consisting of radiotherapy delivered in 25-28 fractions totaling 50-50.4 Gy. Selected patients may also receive chemotherapy and hyperthermia treatments. Blood samples are collected four times before radiotherapy, during the second and last week of radiotherapy, and before surgery. For patients receiving hyperthermia, weekly MR imaging is performed to evaluate tumor morphology and treatment effects. During the study, participants undergo preoperative biopsy and postoperative tumor tissue analysis for immune cell mapping and molecular studies. Blood tests monitor cellular immune status and serum markers like cell-free DNA and HMGB1. Follow-up happens as part of routine cancer care over five years, with the entire study including five years of recruitment and five additional years of follow-up to assess immune responses and tumor changes over time.

Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas