Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and tissue collection for immunological studies, advanced imaging., neoadjuvant Therapy.
- Who it may be relevant to
- Registry conditions: Soft Tissue Sarcoma Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
"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.
Detailed description
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.
Interventions
- Other 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. - Other neoadjuvant Therapy
neoadjuvant Therapy
Primary outcome measures
- Description of the cellular immune status via flow-cytometrie from collected blood samples [Time frame: 5 years of recruitment, 5 years follow-up]
- Description of the cellular immune status on tissue samples ussing komplex immunohistochemie [Time frame: 5 years of recruitment, 5 years follow-up]
- Measurement of the cellular free DNA from collected blood samples [Time frame: 5 years of recruitment, 5 years follow-up]
- Measurement of HMGB1 from collected blood samples [Time frame: 5 years of recruitment, 5 years follow-up]
- Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs [Time frame: 5 years of recruitment, 5 years follow-up]
Eligibility criteria
Inclusion criteria
- Planned histological confirmation for especially high-risk soft tissue sarcoma via open Sampling
- 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
- Age < 18 years
- Poor understanding (language etc.)
- Lack of reconnaissance ability
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Germany · 1 center
- University Hospital Tuebingen — Tübingen
Identifiers
NCT: NCT06385288 · 268/2021BO2