Actively Recruiting
Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
Led by University Hospital Tuebingen · Updated on 2024-12-06
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned histological confirmation for especially high-risk soft tissue sarcoma via open sampling
- Indication for neoadjuvant multimodal therapy including radiation and locoregional hyperthermia, optionally with simultaneous chemotherapy
- Planned surgical resection at the department of the CWS
- Age greater than 18 years
- Ability to give informed consent
- For imaging study: treatment on the combined MR hyperthermia device
You will not qualify if you...
- Age less than 18 years
- Poor understanding of language or related communication
- Lack of ability to recognize or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 6 weeks (duration of radiotherapy in 25-28 fractions)
Participants receive neoadjuvant multimodal therapy including radiotherapy, with possible concomitant chemotherapy and hyperthermia as part of standard treatment. Blood and tissue samples are collected during this period for immunological studies and advanced imaging is performed.
4 blood sampling visits and weekly MR imaging if treated with hyperthermia
Duration - 1 day
Participants undergo surgical resection of the tumor with additional tissue sampling for immunological and molecular analysis.
1 visit (in-person, surgery and tissue collection)
Duration - Up to 5 years
Participants are monitored as part of oncological controls with immunological assessments and imaging continuing for up to 5 years after surgery.
Regular oncological follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
F
Franziska Eckert, MD, Prof.
V
Vlatko Potkrajcic, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here