Clinical trial NCT06385288: Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
Official title: Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma Adult
Keywords: Soft tissue sarcomas
immunological examinations
neoadjuvant therapy
radiotherapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: "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.

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

Primary outcomes:
measure: Description of the cellular immune status via flow-cytometrie from collected blood samples
timeFrame: 5 years of recruitment, 5 years follow-up
measure: Description of the cellular immune status on tissue samples ussing komplex immunohistochemie
timeFrame: 5 years of recruitment, 5 years follow-up
measure: Measurement of the cellular free DNA from collected blood samples
timeFrame: 5 years of recruitment, 5 years follow-up
measure: Measurement of HMGB1 from collected blood samples
timeFrame: 5 years of recruitment, 5 years follow-up
measure: Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs
timeFrame: 5 years of recruitment, 5 years follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Württemberg
Study officials:
References: