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"Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging.
All patients (> 18 Years) with histologically confirmed high-risk soft tissue sarcoma eligible for neoadjuvant multimodal therapy (including radiotherapy +/- concomitant and sequential chemotherapy +/- hyperthermia as well as surgery) are screened for the study. Neoadjuvant therapy consists of 50-50.4 Gy in 25-28 fractions. Additional concomitant or sequential chemotherapy may be applied in selected cases (young patients, high-grade tumors). Additional hyperthermia concomitant to neoadjuvant radiotherapy is applied in selected cases if not contraindicated.
Preoperative tissue sampling to generate primary tumor cell lines in additional translational research is performed in each patient with a lesion suspect for soft tissue sarcoma and eligible for multimodal therapy. Primary cell lines are analyzed biologically (growth pattern, radioresistance, migration, molecular markers RT-PCR, immunological properties such as immunogenic cell death, lysis by cellular immunotherapies such as CAR-NK cells. Postoperative tumor tissues are additionally analyzed for immune cell mapping using complex immunohistochemistry. Biopsy and resection should include proteome analysis and DNA sequencing (only of the tumor tissue, not normal tissue).
Additional immunological monitoring (including cellular immune status, serum marker e.g. cell free DNA, HMGB1) is performed using blood sampling with in total 4 blood controls (25 ml each, before neoadjuvant radiotherapy, during the second and last week of radiotherapy as well as before surgery). In patients treated with concomitant MR-guided hyperthermia, weekly MR-imagine is performed.
Follow-up is carried out as part of the oncological controls over 5 years. The overall study is planned over a period of 5 years (interventional part), additional 5 years follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm trial | Other | Blood and tissue collection for immunological studies under neoadjuvant Therapy of soft tissue sarcomas. Prospective data collection and translational accompanying research on standard therapy. Use of tissue, blood samples and advanced imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and tissue collection for immunological studies, advanced imaging. | Other | Blood and tissue collection for immunological studies under neoadjuvant Therapy of soft tissue sarcomas. Prospective data collection and translational accompanying research on standard therapy. Use of tissue, blood samples and advanced imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the cellular immune status via flow-cytometrie from collected blood samples | Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery. | 5 years of recruitment, 5 years follow-up |
| Description of the cellular immune status on tissue samples ussing komplex immunohistochemie | Tissue samples are taken as incisional biopsie as well as in the tumor tissue after the surgery | 5 years of recruitment, 5 years follow-up |
| Measurement of the cellular free DNA from collected blood samples | Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery. | 5 years of recruitment, 5 years follow-up |
| Measurement of HMGB1 from collected blood samples | Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery. | 5 years of recruitment, 5 years follow-up |
| Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs | Weekly MRIs during neoadjuvant radiation therapy | 5 years of recruitment, 5 years follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franziska Eckert, MD, Prof. | Contact | +49 7071 29 | 82165 | franziska.eckert@med.uni-tuebingen.de |
| Vlatko Potkrajcic, MD | Contact | +49 7071 29 | 82165 | Vlatko.potkrajcic@med.uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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Open Label
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|
| neoadjuvant Therapy | Other | neoadjuvant Therapy |
|
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D014015 | Tissue Banks |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D018070 | Biological Specimen Banks |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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