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Trial Title:
Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
NCT ID:
NCT06385288
Condition:
Soft Tissue Sarcoma Adult
Conditions: Official terms:
Sarcoma
Conditions: Keywords:
Soft tissue sarcomas
immunological examinations
neoadjuvant therapy
radiotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Masking description:
Open Label
Intervention:
Intervention type:
Other
Intervention name:
Blood and tissue collection for immunological studies, advanced imaging.
Description:
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.
Arm group label:
Single-arm trial
Intervention type:
Other
Intervention name:
neoadjuvant Therapy
Description:
neoadjuvant Therapy
Arm group label:
Single-arm trial
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Tuebingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Vlatko Potkrajcic, MD
Phone:
+49 7071 29
Phone ext:
82165
Email:
Vlatko.potkrajcic@med.uni-tuebingen.de
Contact backup:
Last name:
Cihan Gani, MD
Phone:
+49 7071 29
Phone ext:
82165
Email:
cihan.gani@med.uni-tuebingen.de
Start date:
July 21, 2021
Completion date:
July 21, 2031
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385288
