Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
NCT ID: NCT06385288
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-07-21
2031-07-21
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Single-arm trial
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.
Blood and tissue collection for immunological studies, advanced imaging.
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.
neoadjuvant Therapy
neoadjuvant Therapy
Interventions
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Blood and tissue collection for immunological studies, advanced imaging.
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.
neoadjuvant Therapy
neoadjuvant Therapy
Eligibility Criteria
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Inclusion Criteria
* Indication for neoadjuvant multimodal therapy (radiation and locoregional Hyperthermia, optionally with simultaneous chemotherapy)
* Planned resection of a department of the CWS
* Age \> 18 years
* Ability to consent
* Additionally for imaging study: Treatment on the combined MR hyperthermia device
Exclusion Criteria
* Poor understanding (language etc.)
* Lack of reconnaissance ability
18 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Locations
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University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Vlatko Potkrajcic, MD
Role: primary
Cihan Gani, MD
Role: backup
Other Identifiers
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268/2021BO2
Identifier Type: -
Identifier Source: org_study_id