Soft Tissue Sarcoma AdultNCT06385288
Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
A study testing Blood and tissue collection for immunological studies, advanced imaging. and neoadjuvant Therapy in people with Soft Tissue Sarcoma Adult, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma Adult
- What is being tested?
- Blood and tissue collection for immunological studies, advanced imaging. and neoadjuvant Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jul 2021to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Poor understanding (language etc.)
- Lack of reconnaissance ability
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
"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.
Read the 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.
- Conditions
- Soft Tissue Sarcoma Adult
- Being tested
- Blood and tissue collection for immunological studies, advanced imaging., neoadjuvant Therapy
- Keywords
- Soft tissue sarcomas, immunological examinations, neoadjuvant therapy, radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
neoadjuvant TherapyOther
neoadjuvant Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood and tissue collection for immunological studies, advanced imaging.; Other: neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 5 years of recruitment, 5 years follow-up
Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs
Weekly MRIs during neoadjuvant radiation therapy
Measured: 5 years of recruitment, 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start21 Jul 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385288
- Sponsor's protocol ID
- 268/2021BO2
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No